[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Takeda\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":580},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,41,68,93,114,139,162,187,208,230,249,269,293,312,332,352,374,393,413,436,458,485,507,527,560],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100624002","phase-2-a-study-of-zasocitinib-tak-279-in-adults-with-active-crohns-disease-100624002",false,"NCT07403968","A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease","An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease","Inclusion Criteria:\n\n1. Men and women aged 18 to 75 years can participate in the study.\n2. Must have been diagnosed with Crohn's disease (CD) at least 1 month (30 days) before study start.\n3. Must have received other treatments for CD earlier but no longer tolerate these treatments or the treatment no longer helps.\n\nExclusion Criteria\n\n1. Cannot have another condition that causes swelling (inflammation) in the bowel.\n2. Cannot have complications of CD which may require surgery.\n3. Cannot have current abscesses or abscesses that have been treated within 6 weeks before study start.\n4. Cannot have had a removal of parts of the bowel within half a year (6 months) before study start.\n5. Cannot have had any surgery inside the belly (intraabdominal) within 3 months before study start.\n6. Cannot have or had a J-pouch.\n7. Cannot have had infections up to 2 months (8 weeks) before study start.\n8. Cannot have given blood or plasma within 1 month (30 days) before study start.\n9. Cannot tolerate having blood taken with a needle from a vein (venipuncture).\n\nAdditional entry criteria will be discussed with the study doctor.","ALL","18 Years","75 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is.\n\nThe participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy.\n\nDuring the study, participants will visit the study clinic several times.",[28],"Crohn's Disease","NOT_YET_RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":22},"2026-07-15",{"date":37,"type":22},"2028-03-30",{"name":39,"class":40},"Takeda","INDUSTRY",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100643019","phase-2-a-study-of-tak-360-in-adults-with-narcolepsy-type-1-narcolepsy-with-cataplexy-100643019","NCT07633301","A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)","A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)","Key Inclusion Criteria:\n\n1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg\u002Fm\\^2) (inclusive).\n2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.\n\nKey Exclusion Criteria:\n\n1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.\n2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.\n3. The participant has a clinically significant history of head injury or head trauma.\n4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).\n5. The participant has a history of cerebral ischemia, transient ischemic attack (\\\u003C5 years from screening), intracranial aneurysm, or arteriovenous malformation.\n6. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor).\n7. The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody\u002Fantigen at screening.\n8. The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004.\n9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.","70 Years",{"count":50,"type":22},92,[25],"Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \\[EDS\\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).\n\nThe main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.\n\nThe participants will have to visit the clinic multiple times during this study.",[54],"Narcolepsy Type 1",[56,57,58],"Drug Therapy","Narcolepsy With Cataplexy","NT1","RECRUITING","2026-06-26",{"date":30,"type":33},{"date":63,"type":33},"2026-06-04",{"date":65,"type":22},"2027-11-28",{"name":39,"class":40},18,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100567691","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-not-taken-biologic-medicines-100567691","NCT06671483","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines","A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":76,"type":22},1088,[78],"PHASE3","Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.\n\nThe participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.",[81],"Psoriatic Arthritis",[56,83,84,85],"Latitude Research Program","Latitude PsA","Latitude PsA-3001",{"date":30,"type":33},{"date":88,"type":33},"2025-03-03",{"date":90,"type":22},"2028-01-28",{"name":39,"class":40},188,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100567692","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-or-have-not-been-treated-with-biologic-medicines-100567692","NCT06671496","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines","A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR\n   3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":101,"type":22},600,[78],"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.\n\nThe participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.",[81],[56,83,84,106],"Latitude PsA-3002",{"date":30,"type":33},{"date":109,"type":33},"2025-03-10",{"date":111,"type":22},"2028-01-26",{"name":39,"class":40},122,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100642659","phase-2-a-study-of-tak-360-in-people-with-narcolepsy-or-idiopathic-hypersomnia-100642659","NCT07646678","A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia","A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions","Key Inclusion Criteria:\n\n1. Participant is willing and able to understand and fully comply with trial procedures and requirements.\n2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.\n3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.\n\nKey Exclusion Criteria:\n\n1. Participant has a positive pregnancy test or is lactating\u002Fbreastfeeding.\n2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).\n3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).\n4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.\n5. Participant has developed a new history of seizures.\n6. Participant has experienced clinically significant head injury, per investigator opinion.\n7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \\[\\\u003C\\] 5 years ago), or cerebral haemorrhage.\n8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.\n9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.\n10. Participant has developed a history of cancer in the past 5 years.","71 Years",{"count":123,"type":22},500,[25,78],"Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps.\n\nThe study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety).\n\nParticipants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing.\n\nThe participants will have to visit the clinic multiple times during this study.",[127,54,128],"Idiopathic Hypersomnia","Narcolepsy Type 2",[56],"2026-06-25",{"date":132,"type":33},"2026-06-30",{"date":134,"type":33},"2026-06-11",{"date":136,"type":22},"2031-06-15",{"name":39,"class":40},1,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100560759","phase-4-a-study-of-vedolizumab-in-adults-with-ulcerative-colitis-or-crohns-disease-in-the-community-setting-100560759","NCT06581328","A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting","A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting","PANORAMA","Inclusion Criteria\n\nTo be eligible to participate in this study, participants must meet all the following criteria:\n\n1. In the investigator's opinion, the participant can understand and comply with protocol requirements.\n2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.\n3. The participant is 18 to 80 years of age at the time of signing the ICF.\n4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).\n5. If participant is a woman of childbearing potential (WOCBP):\n\n   1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.\n   2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.\n   3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.\n   4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.\n6. If participant is a fertile man:\n\n   1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab\n   2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.\n7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:\n\n   1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \\>=6 (\\>=4 if isolated ileal disease) at screening OR\n   2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening\n8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.\n9. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and\u002For advanced therapy.\n\nExclusion Criteria\n\nParticipants who meet any of the following exclusion criteria will be excluded from participation in this study:\n\n1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\]) at any time prior to screening.\n2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.\n3. Use of corticosteroid enemas\u002Fsuppositories within 2 weeks prior to screening (for UC and CD).\n4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \\[FDA\\] 2024).\n5. Received any investigational biologic therapy \\\u003C= 6 months prior to screening.\n6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12\u002F23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).\n7. The participant has any evidence of an active infection during screening.\n8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.\n9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.\n10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.\n11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.\n12. Has laboratory abnormalities during the screening period.","80 Years",{"count":149,"type":22},400,[151],"PHASE4","Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).\n\nParticipants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.\n\nDuring the study, participants will visit their study clinic several times.",[154,28],"Ulcerative Colitis",{"date":60,"type":33},{"date":157,"type":33},"2025-03-27",{"date":159,"type":22},"2028-06-01",{"name":39,"class":40},101,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":169,"sex":17,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100567196","phase-3-a-study-of-2-doses-of-tetravalent-dengue-vaccine-tdv-in-infants-and-toddlers-100567196","NCT06665035","A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers","A Randomized, Age-Descending, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Immunogenicity of 2 Doses of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Within the Routine Vaccination Schedule of Pediatric Participants ≥6 Months to \u003C21 Months of Age","Inclusion Criteria\n\nParticipant eligibility is determined according to the following criteria:\n\n1. Participant is aged \\>=6 to \\\u003C21 months at the time of entry into the trial.\n2. Participant is male or female.\n3. Participant is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.\n4. Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.\n5. The participant and participant's LAR can comply with trial procedures and can be available for the duration of follow-up, according to the LAR.\n\nExclusion Criteria\n\nAny participant who meets any of the following criteria will not qualify for randomization:\n\n1. Participant has contraindication(s), warning(s) and\u002For precaution(s) applicable to vaccination with TDV as specified in the investigator's brochure (IB)and\u002For the approved product label (as applicable) in the participating country.\n2. Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).\n3. Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.\n4. Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).\n5. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.\n6. Participant has a known or suspected impairment\u002Falteration of immune function, including:\n\n   1. Chronic administration of oral and\u002For parenteral steroids at doses considered sufficiently immunosuppressive (example, \\>=2 mg\u002Fkg \\[milligrams per kilograms\\] body weight\u002Fday prednisone \\[or equivalent\\] for 14 consecutive days, or, \\>=20 milligram per day \\[mg\u002Fday\\] prednisone \\[or equivalent\\] for \\>=14 consecutive days) within 60 days prior to Day 1 month 0 (M0) (note: use of corticosteroids by inhaled, intranasal, intraarticular, bursal, tendon injection, or topical routes is allowed).\n   2. Receipt of blood, immunoglobulins, blood products, and\u002For plasma derivatives within the 3 months prior to Day 1 (M0).\n   3. Receipt of immunostimulants within 60 days prior to Day 1 (M0).\n   4. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).\n   5. HIV infection or HIV-related disease.\n   6. Hepatitis B virus infection.\n   7. Hepatitis C virus infection.\n   8. Genetic immunodeficiency.\n7. Participant has known or suspected abnormalities of splenic or thymic function.\n8. Participant has a known bleeding diathesis, or any condition\u002Fmedication that may be associated with a prolonged bleeding time.\n9. Participant has a serious chronic or progressive disease deemed to be preclusive to trial entry, that is., not medically stable according to the judgment of the investigator.\n10. Participant has previously received a vaccination against dengue virus (investigational or licensed).\n11. Participant has a clinically significant active infection (as assessed by the investigator) or body temperature greater than (\\>) 38.0 degrees Celsius (°C) (\\>100.4 degrees Fahrenheit \\[°F\\]) within 3 days of intended IMP administration on Day 1 (M0).\n12. Participant has used antipyretics and\u002For analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis vs treatment) must be documented. Trial entry must be delayed to allow for a full 24 hours to have passed since last use of antipyretics and\u002For analgesic medications.\n13. Participant has received any of the following:\n\n    1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to IMP administration on Day 1 (M0). This includes co-administration with routine vaccines.\n    2. A coronavirus vaccine within 14 days prior to IMP administration on Day 1 (M0).\n    3. A vaccine authorized for emergency use within 28 days prior to IMP administration on Day 1 (M0).\n14. Participant is scheduled to receive any other vaccine within 28 days after IMP administration on Day 1 (M0).\n15. Participant is participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or plans to participate in another clinical trial at any time during the conduct of this trial.\n16. Participant has taken part in any clinical trial of a dengue or other flavivirus (example, West Nile virus) candidate vaccine, except if it is known that the participant received placebo in the trial(s).\n17. A first degree relative is involved in the conduct of this trial.",true,"6 Months","20 Months",{"count":173,"type":22},212,[78],"Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.",[177],"Dengue Fever",[56],"2026-06-24",{"date":30,"type":33},{"date":182,"type":33},"2025-06-16",{"date":184,"type":22},"2030-03-03",{"name":39,"class":40},4,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100609647","phase-3-a-study-comparing-tak-928-with-docetaxel-in-adults-with-non-small-cell-lung-cancer-100609647","NCT07217301","A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer","A Randomized, Open Label, Multicenter, Phase 3 Trial Evaluating the Efficacy and Safety of TAK-928 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1\u002FPD-L1 Immunotherapy","MarsLight-11","Inclusion Criteria:\n\n1. Must be able to understand and willing to sign the written informed consent form (ICF), be able to comply with the visit schedule and related procedures specified in the protocol.\n2. Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater. For Japan-specific safety run-in (SRI) part of the trial, participants must be Japanese residing in Japan.\n3. Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC. Mixed small cell carcinoma, or other pathological components are excluded.\n\n   Note: For Japan-specific SRI only: Participants' histology is not restricted to squamous NSCLC and may include all metastatic or unresectable solid tumor participants.\n4. Have had disease progression on or after prior treatment with anti-PD-1\u002FPD-L1 therapy and platinum-based doublet chemotherapy (for example, carboplatin and paclitaxel), given either concurrently or sequentially. Eligible participants include those that have:\n\n   \\- Received platinum-based chemotherapy in combination with anti-PD-1\u002FPD-L1 therapy as the only prior line of therapy.\n\n   OR\n\n   \\- Received platinum-based chemotherapy and anti-PD-1\u002FPD-L1 therapy sequentially (in either order) as the only 2 prior lines of therapy.\n\n   Note: For Japan-specific SRI only: Participants must be refractory OR intolerant to standard of care (SOC) treatment.\n5. Participants that have received prior anti-PD-1\u002FPD-L1 therapy with curative intent for locally advanced disease are eligible if they meet either of the following criteria:\n\n   \\- Received prior platinum-based chemotherapy with or without radiotherapy with maintenance anti-PD-1\u002FPD-L1 therapy for Stage III disease and relapsed\u002Fprogressed within 6 months from the last dose of platinum-based chemotherapy.\n\n   OR\n\n   \\- Received prior peri-operative platinum-based chemotherapy with maintenance anti-PD-1\u002FPD-L1 therapy for resectable Stage II\u002FIII and have relapsed within 6 months from the last dose of platinum-based chemotherapy.\n\n   Note: For Japan-specific SRI only: This criterion is not applicable for Japanese participants enrolled in the SRI part of the trial.\n6. Provide formalin-fixed tumor tissue specimen. Fresh biopsies are preferred but archival specimens collected within 2 years before signing the informed consent form are acceptable (blocks or 10-15 unstained slides sectioned 4-5 microns in thickness, if tissue slides, they must be sectioned from blocks less than or equal to (\\\u003C=) 2 months from date of consent). Formalin-fixed paraffin-embedded (FFPE) blocks are preferred for submission; slides should be sent only if there is a local regulation preventing submission of the FFPE block. Ideally, the archival specimen should be collected subsequent to the most recent systemic therapy.\n\n   Note: For Japan-specific SRI only: Collection of tumor tissue specimen is not required for Japanese participants enrolled in the SRI part of the trial.\n7. Have at least 1 measurable lesion (target lesion) by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. Lesions that have previously received radiotherapy or intratumoral injection can only be used as measurable lesions if they show progression after treatment (either pathologically confirmed or with observation of radiographic progression more than 3 months after treatment) as per RECIST V1.1.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n9. Expected survival time greater than or equal to (\\>=) 3 months.\n10. Women of childbearing potential (WOCBP) must take a urine or serum pregnancy test, highly sensitive tests are required where available based on region, and must test negative for trial inclusion. WOCBP must agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception during the entire course of treatment and for 6 months after the last dose of trial treatment. Fertile men must agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s) during the entire course of treatment and for 6 months after the last dose of trial intervention.\n11. Lactating women must agree to strictly abstain from breastfeeding during the entire Treatment Period and for 6 months after the treatment.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding, or intending to become pregnant before, during, or within 6 months after the last dose of any trial intervention. WOCBP not using and\u002For not willing to use at least 1 form of highly effective method of contraception and 1 barrier method of contraception or fertile men with WOCBP partner(s) not using and\u002For not willing to use at least 1 form of acceptable contraception. Note: If in the investigator's judgment, the participant may be pregnant based on the physician's medical interview or other information, the participant will be excluded from the trial irrespective of a negative pregnancy test.\n2. Known actionable genomic alteration, including any of the following driver gene mutations:\n\n   * Epidermal growth factor receptor (EGFR): including exon 19 deletion, exon 21 L858R, exon 20 T790M, exon 20 S768I, exon 21 L861Q, exon 18 G719X, and exon 20 insertion mutations.\n   * Kirsten rat sarcoma virus (KRAS) G12C mutation.\n   * Anaplastic lymphoma kinase (ALK) rearrangement.\n   * ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) rearrangement.\n   * B-Raf proto-oncogene, serine\u002Fthreonine kinase (BRAF) V600E mutation.\n   * Neurotrophic tyrosine receptor kinase (NTRK) 1\u002F2\u002F3 fusion.\n   * MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping mutation.\n   * RET proto-oncogene (RET) rearrangement.\n   * V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2 (ERBB2, also known as HER2) mutation.\n\n   Note: (a) It is not mandatory to have undergone driver gene testing. (b) For Japan-specific SRI only: This criterion is not applicable for Japanese participants enrolled in the SRI part of the trial.\n3. Participants with enlarging or symptomatic brain metastases are excluded from the trial. Participants who are neurologically, clinically and radiologically stable \\>=4 weeks after definitive treatment for brain metastases and participants with small, asymptomatic, incidental, untreated brain metastases that remain radiographically stable \\>=4 weeks after initial identification may participate in this trial as long as they meet all of the following criteria:\n\n   * No metastases to meninges, midbrain, pons, medulla oblongata (leptomeningeal metastases), or cerebellar metastases.\n   * No compression of the aqueduct of Sylvius, no compression of the third or fourth ventricle.\n   * No participant with epidural spinal cord compression or spinal cord metastases.\n   * Participants must be off steroids for at least 7 days for CNS disease. Systemic steroids of \\\u003C=10 milligrams per day (mg\u002Fday) of prednisone or equivalent are acceptable if needed for other indications.\n   * CNS-related symptoms must be stable \\>=14 days prior to randomization\n   * Brain metastases should not be included as RECIST V1.1 target lesions\n4. Presence of any of the following hematologic abnormalities at baseline\\*:\n\n   * Hemoglobin \\\u003C9 grams per deciliter (g\u002FdL).\n   * Absolute neutrophil count (ANC) \\\u003C1,500 per cubic millimeters (mm\\^3).\n   * Platelet (PLT) count \\\u003C100 x 10\\^3\u002Fmm\\^3. \\*\"Baseline\" is defined as the last available observation prior to the first dose of investigational product. Note: Participants must not receive supportive treatments such as blood products (including RBC suspension, apheresis platelets, cryoprecipitation, and so on.) within 7 days of confirming eligibility. Erythropoietin or colony-stimulating factors must not be administered within 28 days of confirming eligibility.\n5. Presence of any of the following serum chemistry abnormalities at baseline:\n\n   * Total bilirubin greater than (\\>) 1.5×upper limit of normal (ULN) except for participants with Gilbert's syndrome with serum bilirubin \\\u003C=3×ULN or if concurrent conjugated bilirubin \\\u003C=ULN.\n   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3×ULN; for liver metastasis, AST or ALT \\>5×ULN.\n   * Creatinine clearance (CrCl) \\\u003C30 milliters per minute (mL\u002Fmin); the Cockcroft-Gault formula is used to calculate CrCl (using ideal body weight for obese participants and actual body weight for non-obese participants).\n   * Albumin \\\u003C30 grams per liter (g\u002FL).\n6. Presence of any of the following coagulation parameter abnormalities at baseline:\n\n   * International normalized ratio (INR) \\>1.5×ULN (\\>3×ULN if on stable dose anticoagulation).\n   * Partial thromboplastin time (PTT; or activated partial thromboplastin time \\[aPTT\\]) \\>1.5×ULN (\\>3×ULN if on stable-dose anticoagulation).\n7. History of deep venous thrombosis, pulmonary embolism, or any other serious thromboembolic events within 30 days prior to enrollment (implantable port or catheter-related thrombosis, or superficial venous thrombosis are not considered \"serious\" thromboembolisms). Participants with a history of serious thromboembolic event must be asymptomatic and on stable anticoagulation therapy (if such therapy is deemed necessary by the treating physician).\n8. Active uncontrolled bleeding, known bleeding diathesis, or significant concern for risk of acute life-threatening bleeding (for example, radiographic evidence that tumor invades large blood vessels or has unclear boundaries with a major vessel \\[including aorta, left pulmonary artery, right pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava, and so on\\], or the investigator judges that the tumor is very likely to invade major vessels with the potential to cause fatal bleeding during the duration of the trial).\n9. Presence of clinically significant cardiovascular or cerebrovascular diseases, including:\n\n   * Symptomatic, clinically unstable arrhythmia or arrhythmia requiring clinical intervention.\n   * Severe conduction disorders (such as third-degree atrioventricular block and bundle branch block).\n   * QT interval corrected for heart rate (QTc interval, calculated using Fridericia's formula) \\>=480 milliseconds (msec).\n   * Uncontrolled hypertension (systolic blood pressure \\>=160 millimeters of mercury (mmHg) or diastolic blood pressure \\>=100 mmHg) despite standard treatment.\n   * History of myocarditis.\n   * Left ventricular ejection fraction \\\u003C50 percent (%).\n   * Congestive heart failure requiring treatment.\n   * Class II to IV cardiac insufficiency according to the New York Heart Association functional classification.\n   * History of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to the first dose of investigational product.\n   * Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of the investigational product.\n   * History of seizures unless controlled on stable dose of antiseizure medications.\n10. Cardiac enzymes \\>=levels consistent with acute myocardial infarction as defined by laboratory-specific criteria. Participants with isolated Grade 1 elevated cardiac enzymes require cardiology clearance and consultation with the sponsor's medical monitor to confirm absence of ongoing myocardial\u002Fischemic disease.\n11. History of or current interstitial lung disease (ILD), pulmonary fibrosis, and drug-related, immune-related and radiation pneumonitis; current active pulmonary infection requiring anti-infective therapy; active pulmonary tuberculosis (TB) within 1 year prior to enrollment; severely impaired pulmonary function, including but not limited to the following: pulmonary embolism, severe asthma or chronic obstructive pulmonary disease within 3 months prior to randomization; autoimmune, connective tissue, or inflammatory diseases involving the lungs (such as rheumatoid arthritis, Sjögren's disease, and sarcoidosis); previous unilateral pneumonectomy.\n\n    Note: Participants with a positive interferon-gamma release assay (IGRA) and negative chest imaging for active pulmonary TB (that is, participants with a history of latent TB) may enroll if they have completed appropriate definitive treatment for latent TB prior to enrollment in the trial (C1D1). Participants with a history of active TB may enroll if they have completed appropriate definitive treatment for active TB more than 1 year before enrollment in the trial (C1D1) and chest imaging at the time of screening is negative for active disease.\n12. History of severe, poorly controlled allergies, asthma or atopic dermatitis (except for atopic dermatitis caused by immunotherapy).\n\n    Note: remote history of childhood asthma is not exclusionary.\n13. Uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, abdominal effusion, pericardial effusion, so on.\n\n    Note: Participants with the following conditions may be enrolled:\n    * Not requiring active drainage.\n    * No significant increase in effusion after stopping drainage determined using at least 2 ultrasound examinations at least 7 days apart.\n14. Current or recent significant gastrointestinal disease or condition, including:\n\n    * Flare of inflammatory bowel disease (within 6 months prior to the first dose of the investigational product).\n    * Grade \\>=2 diarrhea Common Terminology Criteria for Adverse Events (CTCAE V5.0) within 2 weeks prior to the first dose of the investigational product.\n15. Active autoimmune disease requiring systemic treatment (for example, use of disease-modifying drugs, corticosteroids, biologics or immunosuppressants) within 2 years before the first dose.\n\n    Note: Replacement therapies (for example, thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments and exclusionary.\n16. Known history of allogeneic organ transplantation and\u002For allogeneic hematopoietic stem cell transplantation.\n17. Known or suspected allergy to the investigational product and any excipients. Known or suspected severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80.\n18. Prior history of significant toxicity related to immune checkpoint inhibitor (ICI) administration that required permanent discontinuation of this therapy.\n19. Unresolved Grade \\>1 toxicity related to any previous antitumor therapy (excluding alopecia, asthenia, hypothyroidism requiring only thyroid hormone replacement therapy (HRT), hyperglycemia requiring only insulin replacement therapy, adrenal insufficiency requiring physiological steroid replacement, electrolyte abnormalities requiring only symptomatic treatment, and other conditions not affecting the investigational product treatment as assessed by the investigator).\n20. Have not adequately recovered from previous surgery or have undergone any major surgery, within 4 weeks before the first dose of investigational product.\n21. Uncontrolled tumor-related pain or symptomatic hypercalcemia.\n22. Uncontrolled human immunodeficiency virus (HIV), active syphilis, active hepatitis B virus (HBV), or hepatitis C virus (HCV).\n\n    * Participants who are HIV-positive must have CD4 \\>=350 cells per microliter (cells\u002FµL) and must be on established highly active antiretroviral therapy (ensure no expected drug-drug interactions) for at least 4 weeks with an HIV viral load \\\u003C400 copies per milliliter (copies\u002FmL).\n    * Participants with positive results consistent with an untreated syphilis infection cannot enroll.\n\n    Note: Testing with either a treponemal \\[for example, Treponema Pallidum hemagglutination TPHA or Treponema Pallidum particle agglutination TPPA test\\] or nontreponemal \\[for example, rapid plasma reagin (RPR) or Venereal Disease Research Laboratory test\\] assay is acceptable. An initial positive test should be confirmed with an assay using the alternate testing approach (for example, treponemal followed by nontreponemal or vice versa). If the second test is negative, the participant may enroll in the trial.\n    * Participants with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) should undergo HBV DNA testing. If the HBV DNA copy number is \\\u003C=2.5×10\\^3 copies\u002FmL or \\\u003C=500 international units per milliliter (IU\u002FmL) or below the lower limit of detection, the participant can be enrolled. Participants who are HBsAg (+) should receive anti-HBV treatment throughout the treatment period to avoid viral activation. For participants with anti-hepatitis B core antibody (anti-HBcAb) (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment can be considered but is not required; however, close monitoring for viral reactivation is required.\n    * Participants with positive HCV serology results must have an HCV RNA viral load that is negative or below the lower limit of detection.\n    * Participants who have received definitive HCV treatment and have undetectable viral load results are allowed.\n23. Serious\u002Factive\u002Funcontrolled infection, infection requiring systemic intravenous antibiotics, or fever of unknown origin (\\>=38 degree celsius \\[°C\\]) within 2 weeks before the first dose of investigational product.\n24. History or current evidence of any disease, treatment, or laboratory abnormality that, in the judgment of the investigator, could compromise the safety of the participant, interfere with obtaining informed consent, affect participant compliance, or affect safety evaluations of the investigational product.\n25. Psychiatric illness, altered mental status, or drug abuse that prevents understanding of the informed consent process and\u002For completion of required trial-related evaluations.\n26. Unable to meet protocol requirements for known or foreseeable reasons per investigator judgement.\n27. Diagnosed with other pathologically confirmed malignancies within 5 years prior to informed consent, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, papillary thyroid cancer, and other radically treated malignancies with no known active disease for at least 2 years prior to enrollment and with a very low risk of recurrence.\n28. Received any of the following excluded medications or treatments:\n\n    * Docetaxel.\n    * Received more than 1 anti-PD-1\u002FPD-L1 therapy in the metastatic or recurrent unresectable locally advanced setting. Prior anti-PD-1\u002FPD-L1 therapy in the curative locally advanced setting followed by anti-PD-1\u002FPD-L1 therapy in the metastatic or recurrent unresectable locally advanced setting is allowed, not to exceed 2 prior lines of anti-PD-1\u002FPD-L1 therapy in total.\n    * Systemic antitumor therapy except anti-PD-1\u002FPD-L1 therapy and platinum-based doublet chemotherapy including but not limited to bispecific antibodies, targeted therapy, antibody drug conjugate, cell therapies, and other ICIs.\n\nNote: For Japan-specific SRI only: The above listed 3 limitations regarding prior systemic antitumor therapy do not apply to participants enrolled in the Japan-specific SRI cohorts.\n\n* Interleukin (IL)-2 or IL-15 cytokines or related therapies.\n* Chemotherapy within 2 weeks or 5 half-lives (whichever is longer) before the first dose of investigational product without delayed toxicity.\n* Antitumor antibody therapy (excluding antibody drugs such as denosumab for the treatment of bone metastases) within 4 weeks before the first dose of the investigational product.\n* Palliative radiotherapy within 2 weeks prior to the first dose of investigational product.\n* Live vaccine within 28 days prior to the first dose of investigational product.\n* Immunosuppressive or systemic steroid therapy (\\>10 mg\u002Fday of prednisone or equivalent) within 2 weeks prior to the first dose of investigational product.\n* Received traditional Chinese medicine with potential antitumor activity or known antitumor indications within 1 week before the first dose of the investigational product.",{"count":101,"type":22},[78],"Lung cancer is one of the most common forms of cancer. One common type is non-small cell lung cancer (NSCLC). NSCLC happens when abnormal cells in the lungs grow too fast. This can stop the lungs from working normally. This study focuses on NSCLC in later stages (advanced). This means that the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery (unresectable).\n\nPeople with unresectable, advanced or metastatic NSCLC often get treatment with immunotherapy and\u002For platinum-based chemotherapy (such as cisplatin or carboplatin). Immunotherapy helps the body's germ-fighting (immune) system fight cancer. Chemotherapy kills cancer cells or slows their growth. Over time, these treatments may stop working and the cancer can get worse.\n\nResearchers are looking for ways to make immunotherapy work better. One approach is to help the immune system recognize cancer more easily by activating certain cells, called T cells, to attack and kill the tumor cells. TAK-928 is designed to attach to T cells in the tumor and make them more active and abundant. This may help the body fight the cancer and destroy tumor cells.\n\nThe main aim of this study is to learn how well TAK-928 works and compares with the usual treatment (also called standard of care), docetaxel, in adults with unresectable, advanced or metastatic NSCLC. Another aim is to learn how safe TAK-928 is in adults with NSCLC.\n\nThe participants can be treated for up to 2 years (24 months) depending on how a participant responds, side effects, or other reasons. Researchers will check a participant's condition until the treatment is ended.\n\nDuring the study, participants will visit the study clinic several times.",[199],"IO-resistant sqNSCLC","2026-06-23",{"date":60,"type":33},{"date":203,"type":33},"2025-11-26",{"date":205,"type":22},"2029-12-01",{"name":39,"class":40},44,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},"100590162","phase-3-a-study-of-mezagitamab-in-adults-with-kidney-condition-called-iga-nephropathy-100590162","NCT06963827","A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy","A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy","* Inclusion Criteria:\n\nTo be eligible to participate in this trial, participants must meet all the following criteria:\n\n1. Either UPCR greater than or equal to (≥) 0.8 gram per gram (g\u002Fg) or urine protein excretion (UPE) ≥1 grams per day (g\u002Fday), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).\n2. eGFR greater than (\\>)30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).\n3. No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).\n4. The participant is aged ≥ 18 years or the local legal age as applicable.\n5. The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \\[ICF\\]) and any required privacy authorization before the initiation of any clinical trial procedures.\n6. Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.\n7. Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and\u002For angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.\n8. Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.\n9. Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin \\[hCG\\]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).\n10. Any one of the following (only applicable for participants in the open-label cohort):\n\n    1. Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR \\>0.5 g\u002Fg or UPE \\>0.5 g\u002Fd calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\>30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    2. UPCR \\\u003C0.8 g\u002Fg and UPE ≥0.75 and \\\u003C1.0 g\u002Fday, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\> 30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    3. UPCR ≥ 0.8 g\u002Fg or UPE ≥ 1.0 g\u002Fd by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n\n       * Exclusion Criteria:\n\nA participant who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).\n2. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.\n3. Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).\n4. Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \\>3.5 g\u002Fday and hypoalbuminemia (\\\u003C3.0 grams per deciliter \\[g\u002FdL\\]) with or without peripheral edema.\n5. Renal or other organ transplantation prior to or expected during the clinical trial.\n6. Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.\n7. If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:\n\n   1. The last dose was received within 6 months before the signing of the ICF.\n   2. The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.\n\n   Note: Participants who have received the last dose of anti-CD20 treatment \\>12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.\n8. Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.\n9. The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.\n10. Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.\n11. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n12. The participant has had any of the following types of infections within the specified timeframes where applicable:\n\n    1. Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at least 2 weeks before Visit 1.\n    2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.\n    3. Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.\n    4. Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or malnutrition) as judged by the investigator.\n    5. For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis based on local guidelines and in consultation with a pulmonology or infectious disease specialist prior to the first administration of IMP.\n13. In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, infectious disease, immunodeficiency, or alcohol and drug abuse), that poses an added risk for the participant or could confound the assessment of trial results.\n14. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.\n15. The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months before screening.\n\n    Note: Major surgery typically requires at least 1 night in the hospital.\n16. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.\n17. The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.\n18. The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal at screening.\n19. The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.\n20. The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n21. The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for any partner(s) with potential for pregnancy when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n22. In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and\u002For unable to understand and fully comply with clinical trial procedures and requirements (including digital tools and applications).",{"count":216,"type":22},347,[78],"Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.\n\nParticipants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time.\n\nIn the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.\n\nDuring the study, participants will visit their study clinic several times.",[220],"Kidney Disease",[222,56],"TAK-079",{"date":179,"type":33},{"date":225,"type":33},"2025-07-15",{"date":227,"type":22},"2030-01-14",{"name":39,"class":40},170,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":237,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":246,"leadSponsor":248,"locationsCount":138},"100612225","a-study-on-infections-in-adults-with-ulcerative-colitiscrohns-disease-100612225","NCT07250815","A Study on Infections in Adults With Ulcerative Colitis\u002FCrohn's Disease","Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC\u002FCD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025","Inclusion Criteria:\n\nUC Study Cohort:\n\nParticipants will be included if they had:\n\n-Greater than or equal to (\\>=) 1 medical (for Medicare fee-for-service \\[FFS\\], Part A\u002FB) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.\n\nNote: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.\n\nThe date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.\n\n* \\>=2 medical (for Medicare FFS, Part A\u002FB) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.\n* Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.\n\nCD Study Cohort:\n\nParticipants will be included if they had:\n\n\\- \\>=1 medical (for Medicare FFS, Part A\u002FB) or pharmacy claim (for Medicare FFS, Part D) for an approved AMT for CD during the Participant Identification Period.\n\nNote: Claim should be on or after the FDA treatment-specific approval dates for each drug.\n\nThe date of the first claim during the Patient Identification Period will be designated the Index Date, and the corresponding AMT, the index AMT.\n\n* \\>=2 medical (for Medicare FFS, Part A\u002FB) claims, at least 30 days apart, with an ICD-10-CM code for CD during the Baseline Period or on the Index Date.\n* Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.\n\nIf a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.\n\nExclusion Criteria:\n\nParticipants with any of the following will be excluded from the analysis:\n\n* Any evidence of AMT utilization during the Baseline Period.\n* Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.\n* Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.","65 Years",{"count":239,"type":22},23900,"OBSERVATIONAL","More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC\u002FCD, however, might make it easier for older adults to get infections.\n\nThe main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).\n\nThe study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.\n\nData will be collected from existing Medicare databases.",[154,28],"2026-06-19",{"date":200,"type":33},{"date":35,"type":22},{"date":247,"type":22},"2026-12-15",{"name":39,"class":40},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":186},"100590890","phase-3-a-study-of-teduglutide-in-chinese-adults-with-short-bowel-syndrome-100590890","NCT06973304","A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome","An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg\u002Fkg\u002FDay Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support","Inclusion Criteria:\n\n1. Males or females 18 years of age or older at the time of signing the informed consent.\n2. Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease).\n3. Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.\n4. Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs due to ongoing malabsorption.\n5. Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:\n\n   1. Actual PS usage is similar to prescribed PS.\n   2. Baseline (Visit 2) 48-hour intake (I)\u002Foutput (O) volumes should fall within +-25% of the respective 48-hour I\u002FO volumes at the last optimization visit.\n   3. The 48-hour urine output volume must not be less than 2 liters and should not exceed 4 liters at the last optimization visit, the stabilization visit, and the baseline visit.\n6. Participants with a history of Crohn's disease must be in endoscopic remission for at least 12 weeks prior to the baseline visit.\n\nExclusion Criteria:\n\n1. Pregnant or lactating female.\n2. Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent participation in any other clinical study.\n3. Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit.\n4. Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.\n5. Previous use of teduglutide.\n6. Active inflammatory bowel disease (IBD) or any participant with IBD requiring immunosuppressant therapy (example, azathioprine,anti-tumor necrosis factor \\[anti-TNF\\]) drugs) that had been introduced or changed within the past 6 months prior to the baseline visit.\n7. Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis.\n8. Chronic intestinal pseudo-obstruction or severe dysmotility.\n9. Clinically significant intestinal stenosis or obstruction, or evidence of such on upper gastrointestinal (UGI)\u002Fsmall bowel follow-through (SBFT), within the past 6 months prior to the baseline visit.\n10. Major gastrointestinal (GI) surgical intervention, including significant intestinal resection, within the past 3 months (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections less than or equal to \\[\\\u003C=\\] 10 centimeter \\[cm\\], or endoscopic procedure is allowed) prior to the baseline visit.\n11. Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease).\n12. Moderate or severe renal impairment, defined as creatinine clearance less than 50 milliliters per minute (mL\u002Fmin).\n13. Currently diagnosed with cancer or a history of any cancer except surgically cured skin cancer within the past 5 years.\n14. Severe hepatobiliary disease including any of the following:\n\n    1. Total bilirubin level at least 2 times the upper limit of normal (ULN), except for increased indirect (unconjugated) bilirubin in a patient with Gilbert's syndrome.\n    2. AST at least 5\\*ULN.\n    3. ALT at least 5\\*ULN\n15. Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase at least 2\\*ULN.\n16. More than 4 SBS-related or PS-related hospital admissions (example, central line-associated bloodstream infection, bowel obstruction, severe fluid\u002Felectrolyte disturbances) within the past 12 months prior to the baseline visit.\n17. Unscheduled hospitalization within 30 days prior to screening.\n18. Non-herpetic viral diseases:\n\n    1. Presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (ribonucleic acid) (nucleic acid test or polymerase chain reaction).\n    2. Presence of (Hepatitis B Surface Antigen Positive \\[HBsAg+\\]). For participants who are negative for HBsAg but are positive for either surface antibodies and\u002For core antibodies, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction will be performed; if any test result meets or exceeds detection sensitivity, the subject will be excluded.\n    3. Positive results for human immunodeficiency virus (HIV) by serology, regardless of viral load.\n19. Any condition, disease, illness, or circumstance that in the investigator's opinion puts the participant at any undue risk, prevents completion of the study, or interferes with analysis of the study results. Example of potential disease state\u002Fillnesses that may be excluded are listed in the protocol.",{"count":257,"type":22},13,[78],"The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide.\n\nParticipants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment.\n\nParticipants will be in the study for about 65 weeks.",[261],"Short Bowel Syndrome",[56],{"date":179,"type":33},{"date":265,"type":33},"2025-06-26",{"date":267,"type":22},"2027-07-28",{"name":39,"class":40},{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100547216","phase-3-a-long-term-extension-study-of-vedolizumab-in-children-and-teenagers-with-ulcerative-colitis-uc-or-crohns-disease-cd-100547216","NCT06405087","A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)","A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease","Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \\>=2 points and \\>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \\[NCT06100289\\]), including a \\>=1-point decrease in the Mayo stool frequency subscore and a \\>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\\\u003C=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \\\u003C=30 with a reduction in the PCDAI of \\>=15 points from baseline (from VedolizumabSC-3003 \\[NCT06100289\\]).\n\nInclusion Criteria for Observational Cohort\n\n1\\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.\n\nExclusion Criteria for Treatment Cohort\n\n1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.\n2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.","2 Years","17 Years",{"count":279,"type":22},70,[78],"The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.\n\nIn this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \\[NCT06100289\\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.\n\nDuring the study, participants will visit their study clinic several times.",[154,28],[56],"2026-06-18",{"date":286,"type":33},"2026-06-22",{"date":288,"type":33},"2025-10-27",{"date":290,"type":22},"2030-08-12",{"name":39,"class":40},54,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":4},"100641121","a-study-of-fruquintinib-in-adults-with-metastatic-colorectal-cancer-in-poland-100641121","NCT07623174","A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland","FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients","Inclusion Criteria:\n\n1. Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride\u002Ftipiracil.\n2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.\n3. Participants for whom adequate medical records are available to support the data collection requirements.\n\nExclusion Criteria:\n\n1\\. Participant currently participates or plans to participate in an interventional clinical trial.",{"count":301,"type":22},110,"Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.\n\nThe main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.\n\nOther aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.\n\nThe study will look at data already existing in the participants' medical charts.",[304],"Metastatic Colorectal Cancer","2026-06-17",{"date":284,"type":33},{"date":308,"type":22},"2026-07-31",{"date":310,"type":22},"2028-03-31",{"name":39,"class":40},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":319,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100627165","a-study-of-takhzyro-in-teenagers-and-adults-with-hereditary-angioedema-hae-in-south-korea-100627165","NCT07445087","A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea","A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro in South Korea","Inclusion criteria:\n\n1. Participants aged 12 years or older at time of initiation of Takhzyro.\n2. Participants who are treated or will be treated with Takhzyro according to the approved label of South Korea.\n3. The participant or legally authorized representative agrees to participate.\n\nExclusion criteria:\n\n1. Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.\n2. Participant is currently enrolled in an interventional trial.","12 Years",{"count":321,"type":22},35,"Takhzyro is an approved treatment for hereditary angioedema (HAE) in South Korea. HAE is a rare condition which causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. The main aim of this study is to check how safe Takhzyro is in teenagers and adults with HAE in everyday medical care in South Korea. Another aim is to see how well Takhzyro works in everyday medical care.\n\nThe treatment of participants and any check-ups will be determined by the treating doctors according to their normal practice. Participants may visit the study clinic several times during the study.",[324],"Hereditary Angioedema (HAE)",[56],{"date":284,"type":33},{"date":328,"type":22},"2026-10-01",{"date":330,"type":22},"2032-02-29",{"name":39,"class":40},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":340,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100609731","a-study-about-the-diagnosis-and-management-of-hereditary-angioedema-hae-in-egypt-100609731","NCT07218393","A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt","Retrospective and Prospective Real-World Evidence (RWE) Study Investigating Diagnosis and Therapeutic Management of Patients With HAE Type I or II in the Current Medical Practice in Egypt: the EXPLORHAE Study (EXPLORing Prospective and Retrospective Health Assessments of HAE in Egypt)","EXPLORHAE","Inclusion Criteria: Retrospective Phase:\n\n1. The participant has a confirmed HAE-C1INH type1 or type2 diagnosis in medical records (based on clinical history and\u002For laboratory diagnosis in medical records).\n2. The participant was diagnosed and\u002For treated from January 2015 to August 2025.\n\nInclusion Criteria: Prospective Phase:\n\n1. The participant has a physician-confirmed HAE-C1INH type1 or type2 diagnosis (based on clinical history and\u002For laboratory diagnosis).\n2. The participant signed an informed consent or assent.\n3. The participant should have had at least one visit to the treating physician\u002Finvestigator during enrollment and the follow-up period.\n4. The participant was not enrolled in the study's retrospective phase.\n\nExclusion Criteria: (For both retrospective and prospective phases):\n\n1. Participant with AAE-C1INH (acquired angioedema), drug-induced angioedema (AE-DI) (example angiotensin-converting enzyme inhibitors-I \\[ACE-I\\] angioedema), allergic mediated angioedema, inflammatory angioedema, or idiopathic angioedema.\n2. HAE participants with normal C1-INH (HAE-nC1INH).\n3. Participant deemed unsuitable for participation for any reason, based on the investigator's clinical judgment.","1 Year",{"count":342,"type":22},100,"Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency); HAE with C1-INH deficiency can be divided into Type1, with low levels of C1-INH, and Type 2, in which the protein is there, but does not work properly. This study will look at people with HAE Type1 or Type2.\n\nThe main aim of this study is to describe the diagnosis and management of people with HAE Type1 or HAE Type2 in Egypt. Other aims are to learn more about people with HAE Type1 or Type2, including, but not limited to, other conditions they may have, family history, impact of HAE on daily life, if treatment is stopped and the reasons.\n\nDuring the study, information from already existing data in a participant's medical record will be reviewed and new data will be collected during routine visits of a participant to the study clinic.",[324],{"date":284,"type":33},{"date":347,"type":22},"2026-12-01",{"date":349,"type":22},"2027-12-01",{"name":39,"class":40},7,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100614935","phase-3-continuation-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-100614935","NCT07286058","Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis","A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs","Inclusion Criteria:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n2. The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies.\n3. The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy.\n\nExclusion Criteria:\n\n1. Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study.\n2. Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002).\n3. The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n4. The participant has developed evidence of a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":360,"type":22},1182,[78],"Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.\n\nThe purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.\n\nAdults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \\[NCT06671483\\] or TAK-279-PsA-3002 \\[NCT06671496\\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).\n\nEach participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.",[81],[56,84,365],"Latitude PsA-3003","2026-06-16",{"date":305,"type":33},{"date":369,"type":33},"2026-03-11",{"date":371,"type":22},"2029-12-18",{"name":39,"class":40},16,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":276,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":392},"100612311","a-study-of-lanadelumab-in-children-with-hereditary-angioedema-hae-in-multiple-countries-100612311","NCT07251933","A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries","A Multi-national Real-world Outcomes and Treatment Patterns Study of Lanadelumab (Takhzyro) in Paediatric Patients With Hereditary Angioedema (TAHORA)","Inclusion Criteria:\n\n1. Participant is aged 2 to less than (\\\u003C) 12 years at the time of lanadelumab initiation and is expected to have at least 6 months of follow-up information before turning 12.\n2. Participant has physician-confirmed diagnosis of HAE-C1INH.\n3. Participant initiated LTP with lanadelumab during the eligibility period.\n4. Signed consent\u002Fassent (where required by local regulations).\n5. Participant's medical record contains documentation of HAE attacks in the pre-index period and after lanadelumab initiation.\n\nExclusion Criteria:\n\n1. Participant was enrolled in a therapeutic investigational drug (lanadelumab or other drug) or device trial at index date.\n2. Participant with no documented HAE attacks in the 12 months prior to index date.","11 Years",{"count":383,"type":22},40,"HAE is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency). This study will concentrate on children with HAE C1-INH deficiency who have received Takhzyro (Lanadelumab) as prophylactic treatment.\n\nThe main goal of the study is to assess how well lanadelumab works in children with HAE-C1INH deficiency in everyday life. This will be measured by checking how long children who receive lanadelumab will be free of HAE attacks.\n\nOther goals are to understand how children with HAE-C1INH deficiency are being treated with lanadelumab, how well the treatment works for them, how safe it is and how often these children need to use healthcare services (like doctor visits, hospital stays, etc.) because of their condition.\n\nThe study will only look at data already existing in the participants' medical records. No treatment will be given as part of the study.",[324],[56],{"date":284,"type":33},{"date":389,"type":33},"2026-02-05",{"date":132,"type":22},{"name":39,"class":40},24,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":400,"maxAge":277,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":383},"100612224","phase-3-a-long-term-study-of-zasocitinib-in-children-and-teenagers-with-plaque-psoriasis-100612224","NCT07250802","A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis","A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (\\>=) 6 months prior to the screening visit.\n2. Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for \\>=6 months before screening.\n3. Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score \\>=12 and a Static Physician's Global Assessment (sPGA) score \\>=3 at screening and Day 1.\n4. Participant has plaque psoriasis covering \\>=10 percent (%) of total body surface area (BSA) at screening and Day 1.\n5. Participant must be a candidate for phototherapy or systemic therapy.\n6. Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (\\\u003C) 18 years, inclusive.\n7. Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to \\\u003C12 years, inclusive.\n8. Inclusion Criteria for Part A Cohort 1: The participant must weigh \\>=40 kilograms (kg) at the time of screening.\n\nExclusion Criteria:\n\n1. Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.\n2. Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.\n3. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.\n4. Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent tuberculosis infection (LTBI).\n5. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.\n6. Participant has a history of chronic or recurrent bacterial disease.\n7. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).\n8. Participant has any clinically significant medical condition, evidence of an unstable clinical condition or vital signs\u002Fphysical examination\u002Flaboratory\u002FECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results.\n9. Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors or participated in any trial that included a tyrosine kinase 2 (TYK2) inhibitor, unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.\n10. Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.","4 Years",{"count":301,"type":22},[78],"The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it.\n\nThe study will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children.\n\nAt first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib.\n\nParticipants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study.\n\nParticipants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.",[405],"Plaque Psoriasis",[56],{"date":305,"type":33},{"date":409,"type":33},"2025-12-04",{"date":411,"type":22},"2033-01-24",{"name":39,"class":40},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":435},"100589306","phase-2-a-study-of-tak-360-in-adults-with-narcolepsy-without-cataplexy-nt2-100589306","NCT06952699","A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)","A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)","Key Inclusion Criteria:\n\n1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg\u002Fm\\^2) \\[inclusive\\].\n2. The participant has a documented, current diagnosis of NT2.\n\nKey Exclusion Criteria:\n\n1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.\n2. The participant has medically significant thyroid disease.\n3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \\[such as basal cell carcinoma\\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).\n4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody\u002Fantigen (at screening).\n5. The participant has a clinically significant history of head injury or head trauma.\n6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).\n7. The participant has a history of cerebral ischemia, transient ischemic attack (\\\u003C5 years from screening), intracranial aneurysm, or arteriovenous malformation.",{"count":421,"type":22},88,[25],"Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.\n\nThe main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.\n\nParticipants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.",[128],[426,427,428],"Narcolepsy without Cataplexy","NT2","TAK-360",{"date":305,"type":33},{"date":431,"type":33},"2025-05-06",{"date":433,"type":22},"2026-08-20",{"name":39,"class":40},52,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":457},"100451321","phase-3-a-study-of-tak-330-to-reverse-the-effects-of-factor-xa-inhibitors-for-adults-needing-urgent-surgery-100451321","NCT05156983","A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery","A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery\u002FInvasive Procedure","Inclusion Criteria:\n\n* Participant or legally authorized representative willing to sign e-consent\u002Fwritten informed consent form.\n* Participants at least 18 years of age at enrollment.\n* Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).\n* In the opinion of the surgeon, the participant requires an urgent surgery\u002Fprocedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti-Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (\\>) 75 nanograms per milliliter (ng\u002FmL), or heparin calibrated anti-FXa assay levels of \\>0.5 international unit per milliliter (IU\u002FmL) at screening.\n* Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.\n\nExclusion Criteria:\n\n* The participant has an expected survival of less than 30 days, even with best available medical and surgical care.\n* Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.\n* Active major bleeding defined as bleeding that requires surgery or transfusion of \\>2 units of packed red blood cell (PRBC) or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greater than or equal to (\\>=) 9.\n* Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.\n* Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.\n* Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).\n* Platelet count less than (\\\u003C) 50,000 per microliter (\u002FmcL).\n* History of heparin-induced thrombocytopenia.\n* Administration of procoagulant drugs (example, non-study prothrombin complex concentrates (PCCs), recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment. (Note: administration of PRBCs for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).\n* Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these participants in the interactive response technology (IRT). Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.\n* Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.\n* Hypersensitivity to PCC constituents or any excipient of TAK-330.\n* Participants with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.\n* Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) \\>=65 millimeters of mercury (mmHg) and having blood lactate \\>2 millimole (mmol) despite adequate volume resuscitation.\n* Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)\n* Renal failure requiring dialysis\n* Any other condition that could, in the opinion of the investigator, put the participant at undue risk of harm if the participant were to participate in the study.\n* Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.\n* The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.\n* Women who are breastfeeding at the time of enrollment.",{"count":444,"type":22},440,[78],"The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery\u002Finvasive procedure.\n\nThe participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery.\n\nPatients participating in this study will need to be hospitalized. They will also be contacted (via telehealth\u002Fphone call) 30 days after the surgery.",[448],"Coagulation Disorder",[450],"Reversal of Factor Xa inhibitors",{"date":284,"type":33},{"date":453,"type":33},"2022-08-24",{"date":455,"type":22},"2028-08-30",{"name":39,"class":40},64,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":484},"100625426","phase-3-a-study-to-compare-elritercept-with-epoetin-alfa-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100625426","NCT07422480","A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions","ELRiSE MDS","Inclusion Criteria\n\n1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.\n3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\\>) 14 days after red blood cell (RBC) transfusion or greater than (\\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.\n4. Bone marrow less than (\\\u003C) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.\n5. Endogenous serum erythropoietin s (EPO) level of \\\u003C500 U\u002FL. Should be results from blood samples collected \\>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.\n6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units\u002F8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.\n\n   • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g\u002FdL) (5.6 millimoles per liter (mmol\u002FL)) with symptoms of anemia (or ≤7 g\u002FdL \\[4.3 mmol\u002FL\\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.\n\n   • RBC transfusions administered when hemoglobin (Hgb) levels were \\>9.0 g\u002FdL (or \\>7 g\u002FdL in the absence of symptoms) and\u002For RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.\n7. Hgb \\\u003C11.0 g\u002FdL (6.8 mmol\u002FL) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.\n8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria\n\n\u003C!-- -->\n\n1. Prior therapy with any of the following:\n\n   1. Epoetin alfa\n\n      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.\n   2. Darbepoetin\n   3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.\n   4. Immunomodulatory drug (IMiDs) including lenalidomide\n\n      • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.\n   5. Hypomethylating agent\n\n      • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.\n   6. Luspatercept, sotatercept, imetelstat, or elritercept\n   7. Immunosuppressive therapy\n   8. Hematopoeitic cell transplant\n   9. Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n   10. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed\n   11. High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.\n   12. Investigational agent or any other agent intended for treatment MDS treatment\n2. Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.\n3. Known history of diagnosis of acute myeloid leukemia (AML).\n4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.\n5. Clinically significant cardiovascular disease defined as:\n\n   1. New York Heart Association heart disease class III or IV\n   2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during screening\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening\n6. Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.\n7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n   1. Basal or squamous cell carcinoma of the skin;\n   2. Carcinoma in situ of the cervix;\n   3. Carcinoma in situ of the breast;\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n10. History of solid organ or bone marrow transplantation.\n11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.\n12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n13. Body mass index ≥ 40 kilograms per square meter (kg\u002Fm\\^2).\n14. Major surgery within 28 days before randomization.\n15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.\n16. History of allergy\u002Fanaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.\n17. History of pure red cell aplasia and\u002For antibody against erythropoietin (EPO).\n18. Any of the following laboratory abnormalities:\n\n    1. ANC \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002FL).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or ≥450,000\u002FμL (450×109\u002FL).\n    3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).\n    4. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \\\u003C3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    5. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.\n    6. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    7. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    8. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n19. Ongoing participation in another interventional clinical trial.\n20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.\n21. Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.\n22. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n23. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":467,"type":22},300,[78],"The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.",[471,472],"Myelodysplastic Syndrome","Anemia",[474,475],"TAK-226","Drug therapy","2026-06-12",{"date":478,"type":33},"2026-06-15",{"date":480,"type":33},"2026-05-21",{"date":482,"type":22},"2033-10-01",{"name":39,"class":40},154,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":506},"100608758","phase-1-a-study-of-tak-188-in-adults-with-advanced-or-spreading-solid-tumors-100608758","NCT07205718","A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors","An Open-label, Dose Escalation and Expansion, Phase 1\u002F2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TAK- 188, an Anti-CCR8 Antibody-Drug- Conjugate, as a Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Participants ≥18 years or ≥ the local legal age of majority, as applicable, at the time of signing the ICF.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n3. Participants must provide biopsy samples (core needle or other surgical procedure) collected within 28 days prior to C1D1 and also on treatment unless procedure is determined to be unsafe following discussion with sponsor. Participants with an archival biopsy specimen collected within 90 days prior to C1D1 of TAK-188 who have not received any other cancer-specific treatment (with the exception of adjuvant endocrine therapy for a history of breast cancer) at least 14 days prior to the biopsy and throughout the period leading up to C1D1 may use that archival specimen in lieu of a new pretreatment biopsy. Archival biopsy from the same tumor must be provided, if available.\n4. Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:\n\n   1. Absolute neutrophil count (ANC) ≥1500 per microliter (μL), platelet count ≥75,000\u002FμL, and hemoglobin (Hgb) ≥8.0 g\u002FdL without growth factor support for ANC or transfusion support for platelets within 14 days before the first trial treatment dose. Transfusion of packed red blood cells is allowed, post infusion Hgb must be greater than 8.0 g\u002FdL.\n   2. Total bilirubin ≤1.5 times the institutional upper limit of the normal range (ULN). For participants with Gilbert's disease, ≤3 milligrams per deciliter (mg\u002FdL).\n   3. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN or baseline or ≤5.0 × ULN or baseline with liver metastases.\n   4. Albumin ≥3.0 grams per deciliter (g\u002FdL).\n   5. Calculated creatinine clearance CLCR (using the Cockcroft-Gault formula) ≥60 mL\u002Fminute.\n   6. Left Ventricular Ejection Fraction (LVEF) \\>50%, as measured by echocardiogram or multiple-gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of TAK-188.\n5. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE v5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and\u002For autoimmune endocrinopathies with stable endocrine replacement therapy.\n6. Female participants must be:\n\n   1. Postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, or\n   2. Surgically sterile, or\n   3. If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time, from the time of signing the informed consent through 180 days after the last dose of TAK-188, or\n   4. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.\n   5. Periodic abstinence (for example, calendar ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.\n7. Male participants, even if surgically sterilized (that is, status postvasectomy), must:\n\n   1. Agree to practice effective barrier contraception (that is, a condom) during the entire trial treatment period and through 180 days after the last dose of TAK-188, or\n   2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.\n   3. Periodic abstinence (for example, calendar ovulation, symptothermal, postovulation methods), withdrawal, and spermicides only are not acceptable methods of contraception.\n8. Voluntary written consent must be given before performance of any trial-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.\n9. Participants with controlled Human Immunodeficiency Virus (HIV) are allowed:\n\n   1. Cluster of differentiation 4 (CD4) cell count greater than 350 cell per cubic millimeters (cell\u002Fmm\\^3).\n   2. Viral load undetectable for at least a year.\n10. The following solid tumor participants will be allowed:\n\n    a. Participants with the following pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic solid tumors, who have progressed on all standard, curative, or life-prolonging treatments (or are intolerant to all available standard therapies): i. Gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma and squamous cell carcinoma.\n\n    ii. PDAC. iii. Nonsquamous and squamous NSCLC (participants with actionable genomic alteration \\[AGAs\\] are allowed in dose escalation only).\n\n    iv. squamous cell carcinoma of head and neck (SCCHN). v. Colorectal cancer.\n11. Participants with metastatic or advanced solid tumors must have radiographically measurable disease per RECIST Version 1.1. Lesions to be used as measurable disease for the purpose of response assessment must either a) not reside in a field that has been subjected to prior radiotherapy or b) have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and before trial enrollment or c) have been radiated at least 6 months before trial enrollment or d) should not be the same lesion selected for mandatory biopsy at screening.\n12. For expansion in NSCLC (post programmed cell death-ligand 1 \\[PD-L1\\] treatment):\n\n    1. Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic NSCLC.\n    2. Participants must have tested negative for a known AGA (for example, estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), mesenchymal epithelial transition \\[MET\\], c-ros oncogene 1 \\[ROS1\\], BRAF).\n    3. Must have had disease progression in the advanced or metastatic setting. No more than 1 line of therapy in advanced or metastatic setting is permitted.\n    4. Participants must have received at least 6 weeks of 1 prior anti-PD-(L)1 therapy, and this must have been given during the immediately preceding line of therapy. Anti-PD-(L)1 therapy may have been given in the metastatic or neoadjuvant setting.\n    5. Participants are eligible regardless of PD-L1 status but this information must be provided.\n    6. NOTE: Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA-4 antibody and\u002For chemotherapy (for example, carboplatin and pemetrexed).\n13. For Phase 1 backfill and possible expansion, in SCCHN (post PD-(L)1 treatment):\n\n    1. Participants with histologically confirmed (cytological diagnosis is acceptable) metastatic or unresectable, recurrent SCCHN that is considered incurable by local therapies. Participants should have PD-(L)1 monotherapy or in combination with chemotherapy administered in the recurrent or metastatic setting or neo-adjuvant\u002Fadjuvant. Anti-PD-(L)1 therapy must have been given during the immediately preceding line of therapy. No more than 1 line of therapy in advanced or metastatic setting is permitted.\n    2. Anatomic subsites to be included are oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, and paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal). The exception to this is nasopharyngeal cancer and salivary gland tumors, which will not be included.\n    3. Participants with oropharyngeal cancer or tumors arising in the paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal) must agree to provide archival tissue for human papillomavirus (HPV) testing or if known, HPV testing results using CINtec p16 histology assay and a 70% cutoff point must be provided. If HPV status was previously tested using this method, no additional testing is required. Otherwise, if another validated HPV assay was performed, tissue will be required for central confirmation.\n    4. Tumors must have a PD-L1 CPS ≥1.\n14. For dose expansion in gastroesophageal adenocarcinoma (GEA) (post PD-(L)1 treatment):\n\n    1. Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma.\n    2. Must have had disease progression while on or following 1 prior line of therapy:\n    3. Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. Prior anti-PD-(L)1 therapy may have been given with or without chemotherapy (for example, mFOLFOX or CAPOX); CAPOX); HER-2 positive participants must have received trastuzumab. Anti-PD-(L)-1 therapy must have been given during the immediately preceding line of therapy. No more than 1 line of therapy in advanced or metastatic setting is permitted.\n    4. Tumors must have a PD-L1 CPS ≥1.\n\nExclusion Criteria:\n\n1. History of any of the following cardiac illnesses within 6 months before first dose of TAK-188:\n\n   1. Congestive heart failure New York Heart Association Grade III or IV.\n   2. Unstable angina, myocardial infarction.\n   3. Persistent hypertension ≥160\u002F100 mm mercury (Hg) despite optimal medical therapy.\n   4. Ongoing cardiac arrhythmias of Grade \\>2 (including atrial flutter\u002Ffibrillation or intermittent ventricular tachycardia).\n   5. Other ongoing serious cardiac conditions (for example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy).\n   6. Symptomatic cerebrovascular events.\n   7. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.\n2. Baseline prolongation of Fridericia-corrected QT interval (QTcF) (for example, repeated demonstration of QTc \\>480 milliseconds, history of congenital long QT syndrome, or torsades de pointes) on a 12-lead ECG during the screening period. If participants are taking medications known to prolong QTc at screening, participants may continue to take these medications as long as their baseline QTcF is \\\u003C480 milliseconds. Participants may not start using such medications on or after C1D1.\n3. Oxygen saturation of \\\u003C90% of room air at screening.\n4. Participants treated with other chemokine (C-C motif) receptor 8 (CCR8) targeting agents within the past 6 months.\n5. Active diagnosis of lung conditions including:\n\n   1. Pneumonitis.\n   2. Interstitial lung disease.\n   3. Severe chronic obstructive pulmonary disease.\n   4. Idiopathic pulmonary fibrosis.\n   5. Other restrictive lung diseases.\n   6. Acute symptomatic pulmonary embolism.\n   7. Grade ≥2 pleural effusion not controlled by tap or requiring indwelling catheters.\n6. History of known brain metastasis or leptomeningeal disease unless:\n\n   1. Brain metastases are stable on cranial imaging (that is, ≥4 weeks) following prior surgery, whole-brain radiation OR\n   2. Stereotactic radiosurgery and off corticosteroids for brain metastases\n   3. Must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs.\n7. Grade ≥2 fever of malignant origin.\n8. Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of TAK-188 or severe infections on continued treatment.\n9. Participants with uncontrolled, known or suspected, autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n10. Participants with a diagnosis of an identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, uncontrolled HIV infections, organ transplantation).\n11. Chronic, active hepatitis (for example, participants with known hepatitis B surface antigen seropositive and\u002For detectable HCV RNA). Note:\n\n    1. Participants who have positive hepatitis B core antibody can be enrolled but must have an undetectable serum hepatitis B virus-DNA.\n    2. Participants who have positive HCV antibody must have an undetectable HCV-RNA serum level.\n12. Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.\n13. Any pre-existing medical or psychiatric condition or illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug or that would limit compliance with trial requirements or compromise ability to provide written informed consent. Participants with a history of PE on anti-coagulation are permitted unless symptomatic requiring oxygen supplementation.\n14. Recent major surgery where the participant has not fully recovered based on physician assessment.\n15. Recent major bleeding event that has not resolved, and the underlying reason for bleeding has not been corrected.\n16. Participant with concurrent malignancy requiring active treatment, with the exception of participants on chronic hormonal therapy.\n17. Treatment with fully human\u002Fhumanized antineoplastic monoclonal antibodies less than 4 weeks or the time period equal to the dosing interval, whichever is shorter. No washout period is required for prior treatment with anti-PD-(L)1 antibodies.\n18. Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of TAK-188.\n19. Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy (with the exception of adjuvant endocrine therapy for a history of breast cancer). Concurrent use of hormones for noncancer-related conditions is acceptable (except for corticosteroid hormones).\n20. Radiation therapy within 14 days (42 days for radiation to the lungs) and\u002For systemic treatment with radionuclides within 42 days before C1D1 of TAK-188. Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.\n21. Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of C1D1 of TAK-188, with the following exceptions:\n\n    1. Topical, intranasal, inhaled, ocular, intra-articular, and\u002For other nonsystemic corticosteroids.\n    2. Physiological doses of replacement steroid therapy (for example, for adrenal insufficiency).\n    3. Single doses of steroids (for example, for imaging premedication) within the 7-day timeframe may be allowed after clarification with sponsor.\n22. Receipt of live attenuated vaccine (for example, tuberculosis Bacillus Calmette-Guerin vaccine, oral polio vaccine, measles, rotavirus, yellow fever) within 28 days of C1D1 of TAK-188. Non-live, approved vaccines are allowed (for example, COVID-19 vaccine).\n\n    a. Note: COVID-19 vaccination should not be given within ±3 days of systemic trial treatments.\n23. Recipients of stem cell transplantation or organ transplantation.\n24. Female participants who are lactating or have a positive serum\u002Furine pregnancy test during the screening period or a positive serum\u002Furine pregnancy test on Day 1 before first dose of TAK-188.\n\n    a. Note: Female participants who are lactating will be eligible if they choose to discontinue breastfeeding before the first dose of TAK-188.\n25. Participant is a trial site employee, a site employee's immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with a site employee who is involved in conduct of this trial or may consent under duress.\n26. Participant is considered to be vulnerable, as defined per local regulations and if exclusion is required by local regulations. Examples are persons under safeguard of justice, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care without their consent, persons admitted to a health or social establishment for purposes other than research, persons of full age who are subject to a legal protection measure (guardianship or curatorship), and persons unable to express their consent.",{"count":493,"type":22},223,[495,25],"PHASE1","TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer. TAK-188 may help to remove these Tregs. Removing these Tregs may allow more cancer-fighting cells (CD8+ T cells) to attack the tumor and potentially stop tumors from growing.\n\nIn this study, researchers want to learn if TAK-188 can help the body's immune system better fight cancer in adults with advanced cancers which have not gotten better with regular treatments. The main aims of this study are to check if TAK-188 is safe in adults with advanced or spreading (metastatic) solid tumors, if participants tolerate the treatment with TAK-188 and to learn if TAK-188 works well in adults with certain advanced cancers after their previous treatments didn't work. Participants may receive TAK-188 for up to 1 year. Their health will be monitored after the treatment has ended for up to another year.",[498],"Advanced or Metastatic Solid Tumors",[56],{"date":478,"type":33},{"date":502,"type":33},"2025-11-19",{"date":504,"type":22},"2029-12-21",{"name":39,"class":40},15,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":279},"100601268","phase-2-a-study-of-zasocitinib-in-adults-with-nonsegmental-vitiligo-100601268","NCT07108283","A Study of Zasocitinib in Adults With Nonsegmental Vitiligo","A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants With Nonsegmental Vitiligo","Inclusion criteria:\n\nParticipant willingness:\n\n1. Participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.\n2. Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.\n\n   Disease Characteristics:\n3. Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI greater than or equal to (\\>=) 0.5 and a T-VASI \\>= 5 and less than or equal to (\\\u003C=) 50 at screening and Day 1.\n\n   Age and Reproductive Status:\n4. Participant is aged \\>=18 years to \\\u003C=75 years old at the time of consent.\n5. Participant meets the following birth control requirement:\n\n   An individual with potential for pregnancy who is now of nonchildbearing potential with laboratory confirmation of postmenopausal status; or an individual with potential for pregnancy who if sexually active with a nonsterilized individual who produces sperm, agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial. The use of effective contraception will be required for assigned male sex at birth participants. In the European Union (EU) \u002F European Economic Area (EEA) and the United Kingdom (UK), for participants who elect to use hormonal contraception as a form of highly effective contraception, the investigator must document a favorable benefit-risk assessment to justify the participant's inclusion in the trial at screening and every 3 months during the trial.\n6. For participants in the EU\u002FEEA or UK, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission decision as of 10 March 2023 on measures to minimize risk of serious side effects with Janus Kinase inhibitor (JAKi) (EMA\u002F142279\u002F2023) and the UK MHRA guideline on JAKi: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality as of 26 April 2023 (Drug Safety Update volume 16, issue 9).\n\nExclusion Criteria:\n\nTarget Disease-Related Exclusions:\n\n1. Participant has segmental vitiligo (including mixed vitiligo) or any other congenital or acquired cause of hypopigmentation or depigmentation that could interfere with the diagnosis or assessment of nonsegmental vitiligo.\n2. Participant has \\>50 percent (%) leukotrichia on the face or \\>50% leukotrichia of the body (includes the face), within the skin affected by vitiligo.\n3. Participant requires immunomodulatory or immunosuppressive systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (for example, inflammatory bowel disease).\n4. Participant has a history of phototherapy (including, but not limited to, broadband Ultra-Violet \\[UV\\]-B, narrowband UV-B, psoralen and UV-A, excimer or other laser therapy, or tanning booth use) within 8 weeks before Day 1. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.\n5. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.\n6. History of any depigmenting or bleaching treatment for vitiligo or other skin disorder (for example, monobenzone or phenol).\n7. History of any surgical treatments for vitiligo.\n8. History of recent or progressive undiagnosed hearing loss.\n\n   Recent\u002FConcurrent Infectious Disease Exclusions:\n9. Tuberculosis (TB):\n\n   1. Participant has history of active TB infection, regardless of treatment status.\n   2. Participant has signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.\n   3. Participant has evidence of Latent Tuberculosis Infection (LTBI) as evidenced by a positive QuantiFERON (QFT) result OR 2 indeterminate QFT results and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis. Participant remains eligible if there are no signs\u002Fsymptoms of active TB AND documentation of no history of active TB can be provided AND (1) participant can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines) or (2) participant has a positive QFT result or 2 indeterminate QFT results but has initiated prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. In the EU\u002F EEA and the UK, participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (for example, pulmonologist).\n   4. Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest Computed Tomography (CT), magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all participants regardless of QuantiFERON-TB Gold results unless the participant has had normal chest imaging in the 6 months prior to screening. CT imaging is allowed per local sites requirements.\n10. Herpes infections:\n\n    1. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and\u002For medical history) at screening or Day 1.\n    2. Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).\n11. Non-herpetic viral diseases:\n\n    1. Participant has presence of Hepatitis C Virus (HCV) antibody and a positive confirmatory test result for HCV Ribonucleic Acid (RNA) (nucleic acid test or polymerase chain reaction). In the EU\u002FEEA and the UK, if the participant has total anti-HCV antibody positivity at screening but is confirmed to have no detectable HCV RNA by Polymerase Chain Reaction (PCR) testing, HCV RNA PCR testing will be assessed at additional visits per Schedule of Activities (SoA).\n    2. Participant has presence of positive Hepatitis B surface antigen (HBsAg), or indeterminate HBsAg, presence of Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) (regardless of serology), or positive anti- Hepatitis B core antibody (HBcAb) without concurrent positive HBsAb. In the EU\u002FEEA and the UK, if the participant has total anti-HBc antibody positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, the participant will repeat HBV DNA PCR testing at additional visits per SoA; if a participant has anti-HBsAb positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, unless the participant has documented completion of the HBV vaccination series by medical records, the participant will repeat HBV DNA PCR testing at additional visits per SoA. Note: For other countries in which there are hepatitis B screening guidelines, these can be done per local regulations or site's standard of care.\n    3. Participant has positive results for Human Immunodeficiency Virus (HIV) by serology, regardless of viral load.\n12. Other infectious diseases:\n\n    1. Participant has a history of active infection or febrile illness (with or without other symptoms) within 7 days prior to Day 1, as assessed by the investigator.\n    2. Participant has a history of serious or severe infection within 30 days prior to Day 1, as assessed by the investigator.\n    3. Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy within 30 days prior to Day 1.\n    4. Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis\u002Fpneumonitis, osteomyelitis, or chronic skin ulcerations\u002Finfections or fungal infections (except superficial onychomycosis).\n    5. Participant has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced at least 60 days prior to Day 1.\n    6. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).\n    7. Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.\n\n    Noninfectious Disorders Exclusions:\n13. Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurologic, nutritional, ophthalmologic or immunologic), or vital signs\u002Fphysical\u002Flaboratory\u002FElectrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:\n\n    1. Participant has a history of known or suspected condition\u002Fillness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.\n    2. Participant has a history of new or unstable autoimmune disease (including but not limited to thyroid disease, lupus, sjogrens, myasthenia gravis, or rheumatoid arthritis).\n    3. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.\n    4. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.\n    5. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.\n    6. Participant has a history of cancer or lymphoproliferative disease with the exception of successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix. In the EU\u002FEEA and the UK, for the participants with a history of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix, investigators must document a favorable benefit-risk assessment.\n    7. For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1, or participant has been hospitalized within 3 months prior to Day 1.\n    8. Participant has any of the following cardiovascular disease history:\n\n       * A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening.\n       * Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator documents there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll; in the EU\u002FEEA and the UK, investigators must document a favorable benefit-risk assessment.\n    9. Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if they participated in the trial, in the opinion of the investigator.\n    10. Participant has any lifetime history of suicide attempts, suicidal behavior, or active suicidal ideation with intent and plan based on medical history or a YES response to Columbia-Suicide Severity Rating Scale (C-SSRS) Questions 5; the participant has evidence of current active suicidal ideation based on YES response to questions 2, 3, 4, or 5 on C-SSRS Since Last Visit performed on Day1; or is clinically deemed to have a suicide risk by the investigator.\n    11. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.\n\n    Laboratory\u002FPhysical Exclusions:\n14. Participant has any of the following laboratory values at the screening visit:\n\n    1. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) values \\>=3 times the Upper Limit of Normal (ULN).\n    2. Total bilirubin (unconjugated and\u002For conjugated) ˃1.5 times the ULN.\n    3. Hemoglobin (Hgb) \\\u003C9.0 gram\u002Fdeciliter (g\u002FdL) (\\\u003C90.0 gram\u002FLiter \\[g\u002FL\\]).\n    4. Absolute white blood cell count less than (\\\u003C) 3.0 \\* 10\\^9\u002FLiter (L) (\\\u003C3000\u002Fcubic millimeter \\[mm\\^3\\]).\n    5. Absolute neutrophil count of \\\u003C1.0 \\* 10\\^9\u002FL (\\\u003C1000\u002Fmm\\^3).\n    6. Absolute lymphocyte count of \\\u003C0.5 \\* 10\\^9\u002FL (\\\u003C500\u002Fmm\\^3).\n    7. Platelet count \\\u003C100 \\* 10\\^9\u002FL (\\\u003C100,000\u002Fmm\\^3).\n    8. Thyroid Stimulating Hormone (TSH) outside the normal reference range AND free T4 or T3 outside the normal reference range.\n    9. Estimated creatinine clearance \\\u003C45 milliliter\u002Fminute (mL\u002Fmin) based on the Cockcroft-Gault calculation.\n    10. Creatine Phosphokinase (CPK) \\> ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or lower (or \\\u003C=2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for symptoms of rhabdomyolysis, and for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.\n15. Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.\n16. Participant does not tolerate venipuncture or inability to be venipunctured.\n\n    Allergies and Adverse Drug Reactions Exclusions:\n17. Participant has a history of significant drug allergy (such as anaphylaxis).\n18. Participant has a known or suspected allergy to zasocitinib or any of its components.\n\n    Other Exclusions:\n19. Participant has a positive pregnancy test result or plans to become pregnant during the trial period, including plans to undergo in vitro fertilization, donate ova (eggs), or sperm, or participant is lactating\u002Fnursing.\n20. Participant has given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans to donate blood during the course of the trial.\n21. Participant is compulsorily detained for treatment of either a psychiatric or physical (for example, infectious disease) illness, or is committed to an institution (for example, prison) by virtue of an order issued either by judicial or administrative authorities.\n22. Participant is a trial site employee, an immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with trial site employee who is involved in the conduct of this trial or may consent under duress.\n23. History of rhabdomyolysis.",{"count":515,"type":22},200,[25],"Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches).\n\nThe main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo.\n\nThe participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months.\n\nDuring the study, participants will visit their study clinic 11 times.",[519],"Nonsegmental Vitiligo",[56],{"date":476,"type":33},{"date":523,"type":33},"2025-11-03",{"date":525,"type":22},"2027-11-09",{"name":39,"class":40},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"100571590","phase-3-a-study-of-mezagitamab-in-adults-with-chronic-primary-immune-thrombocytopenia-100571590","NCT06722235","A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia","Key Inclusion Criteria:\n\n1. The participant has been diagnosed with ITP that has persisted for at least 12 months.\n2. The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist \\[TPO-RA\\]), defined as having achieved a platelet count ≥50,000\u002FμL.\n3. The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000\u002FμL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.\n4. The participant has a mean platelet count of less than (\\\u003C)30,000\u002FμL.\n5. If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.\n6. If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.\n\nKey Exclusion Criteria:\n\n1. The participant has secondary ITP.\n2. The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).\n3. The participant has had a splenectomy.\n4. The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).\n5. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.\n6. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n7. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening, and either of the following applies:\n\n   1. The last dose was received within 6 months before screening.\n   2. The last dose was received between 6 and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.\n8. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.\n9. The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.\n10. The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.\n11. The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.\n12. The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.\n13. The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1.\n14. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab\u002Fplacebo formulation.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":535,"type":22},171,[78],"Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \\[SC\\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.\n\nThe participants will be treated with mezagitamab for up to 6 months.\n\nDuring the study, participants will visit their study clinic several times.\n\nParticipants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).",[539],"Immune Thrombocytopenic Purpura (ITP)",[541,222,542,543,544,545,546,547,548,549,550,551,552],"Thrombocytopenia","Blood Platelet Disorders","Hematologic Diseases","Cytopenia","Purpura","Hemorrhagic Disorders","Autoimmune Diseases","Immune System Diseases","Hemorrhage","Skin Manifestations","Purpura, Thrombocytopenic, Idiopathic","Purpura, Thrombocytopenic",{"date":476,"type":33},{"date":555,"type":33},"2025-02-27",{"date":557,"type":22},"2028-03-16",{"name":39,"class":40},114,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":579,"locationsCount":4},"100641830","phase-2-a-study-of-rusfertide-in-japanese-adults-with-polycythemia-vera-100641830","NCT07648030","A Study of Rusfertide in Japanese Adults With Polycythemia Vera","A Phase 2 Open-label Trial to Evaluate the Efficacy and Safety of Rusfertide in Japanese Patients With Polycythemia Vera","Inclusion Criteria:\n\n1. Japanese male and female participants aged 18 years or older at the time of signing informed consent.\n2. Participant understands the trial procedures, is willing and able to adhere to trial requirements and agrees to participate in the trial by giving written informed consent.\n3. Meet revised 2016 WHO criteria for the diagnosis of PV.\n4. Phlebotomy requiring defined as ALL of the following:\n\n   1. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before trial intervention or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before trial intervention, and\n   2. Last phlebotomy due to inadequate hematocrit control within 3 months before trial intervention, and\n   3. No phlebotomy within 6 days prior to trial intervention (do not include day of phlebotomy and day of trial intervention in the 6-day count).\n\n   Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy.\n5. Hematology test values at screening:\n\n   1. Hematocrit \\\u003C45%\n   2. WBC 4,000\u002FµL to 20,000\u002FµL (inclusive), and\n   3. Platelets 100,000\u002FµL to 1,000,000\u002FµL (inclusive).\n6. ECOG performance status 0, 1 or 2.\n7. WOCBP agree to use at least 1 form of highly effective contraception during the trial and for 30 days after the last dose of trial intervention.\n8. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for a period of 30 days after receiving the last dose of trial medication.\n9. A fertile man agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s) during the trial and for 90 days after the last dose of trial intervention.\n10. A male participant must agree not to donate sperm for the purpose of reproduction during the trial and for a minimum of 90 days after receiving the last dose.\n11. Participants receiving CRT at trial intervention must be on a stable PV therapy regimen as follows:\n\n    1. Hydroxyurea - at least 8 weeks\n    2. JAK inhibitor - at least 8 weeks\n    3. Interferon - at least 24 weeks. Note: A \"stable dose regimen\" of CRT does not mean an unchanged dose regimen. Temporary adjustments in dose regimen or temporary suspension of dosing are allowed. However, the total weekly dose of hydroxyurea and JAK inhibitor or total monthly dose of interferon may not be higher at trial intervention than the dose at the beginning of the pre-trial intervention observation period. The pre-trial intervention observation period is 8 weeks for hydroxyurea and JAK inhibitor and 24 weeks for interferon.\n12. Participants treated with phlebotomy alone at trial intervention must have stopped:\n\n    1. Hydroxyurea at least 8 weeks before trial intervention\n    2. JAK inhibitor at least 8 weeks before trial intervention\n    3. Interferon at least 24 weeks before trial intervention.\n\nExclusion Criteria:\n\n1. Clinically meaningful laboratory abnormalities at Screening including, but not limited to:\n\n   1. eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m\\^2 as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese\\*\n\n      \\*eGFR=194×(serum creatinine value)-1.094×(age)-0.287×(sex correction factor), Sex correction factor: 0.739 in female (Japanese Society of Nephrology,2023).\n   2. ALT or AST ≥2.5×ULN\n   3. Total bilirubin \\>1.5×ULN. Note: Screening laboratory tests with abnormal results (if considered by the investigator to be transient and inconsistent with the participant's clinical condition) may be repeated within the screening window to confirm abnormal results. If results return to protocol acceptable limits within the screening period, the participant may enter the trial. Use local labs for all eligibility lab tests.\n2. Participants who require phlebotomy at hematocrit levels lower than 45%.\n3. Pregnant females will be ineligible to participate in this trial if, despite a negative pregnancy test, the investigator determines that based on interview, clinical assessment, or other relevant information that the individual may be in the very early stages of pregnancy.\n4. Is capable of breastfeeding but does not agree to forego breastfeeding from the first dose of trial intervention through 30 days after the last dose of trial intervention.\n5. Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to trial intervention.\n6. Active or chronic bleeding within 2 months prior to trial intervention.\n7. Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).\n8. Any infection requiring systemic therapy within 1 month of dosing except controlled: HIV, hepatitis B, and hepatitis C. Prophylactic therapies are allowed.\n9. Any serious or unstable medical condition (eg, poorly controlled HIV infection) or uncontrolled psychiatric condition as judged by the investigator that would impair the participant's ability to participate in the trial.\n10. Major surgical procedure within 2 months prior to trial intervention unless the participant has fully recovered from surgery or planned major elective surgery during the trial.\n11. History of invasive malignancies within the last 5 years, except\n\n    1. localized cured cancer (eg, prostate cancer and cervical cancer)\n    2. localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.\n12. Participants with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during the required dermatology examination at screening unless the cancer is adequately treated (ie, treatment that is expected to be curative, such as Mohs surgery) before trial intervention. Note: Suspicious lesions should be biopsied and results available before trial intervention.\n13. Participants with active alcohol or drug addiction that would interfere with their ability to comply with trial requirements.\n14. Participants who do not complete at least 4 days of MFSAF v4.0 assessments within 1 week prior to trial intervention.\n15. Receipt of an investigational agent within 2 months or 5 half-lives, whichever is longer, prior to trial intervention.\n16. Received busulfan within 7 months prior to screening.\n17. Participants with hypersensitivity to rusfertide or to any of the excipients.\n18. Participants with any lesion or mass detected by physical examination or imaging during screening that is suspicious for malignancy unless evaluated and assessed to be not malignant.",{"count":568,"type":22},9,[25],"Polycythemia vera (PV) is a rare blood cancer in which the body makes too many red blood cells. This can make the blood thicker and may increase the risk of serious health problems such as blood clots. Many people with PV need regular phlebotomy, which is a procedure to remove blood, to help keep their hematocrit level under control. Hematocrit is the proportion of red blood cells in the blood.\n\nThe main aim of this study is to evaluate whether rusfertide helps Japanese participants with PV keep their hematocrit under control and avoid the need for phlebotomy. All participants in this study will receive rusfertide. This study is open-label, which means both the participants and the study team will know what treatment is being given.\n\nParticipants will be followed for up to about 244 weeks, including a screening period, a 52-week initial treatment period, a long-term extension period, and a 4-week safety follow-up period.",[572],"Polycythemia Vera",[56],"2026-06-10",{"date":478,"type":33},{"date":200,"type":22},{"date":578,"type":22},"2030-05-17",{"name":39,"class":40},""]