[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Georgia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":635},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,151,0,25,[9,55,77,100,134,156,178,209,222,243,273,299,321,344,373,398,421,449,471,497,506,530,556,581,605],{"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":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053387","phase-3-a-study-evaluating-the-efficacy-and-safety-of-pegozafermin-in-participants-with-mash-and-fibrosis-enlighten-fibrosis-100053387",false,"NCT06318169","A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)\n* Biopsy-confirmed MASH with fibrosis stage F2 or F3\n* Body mass index (BMI) at screening ≥25.0 kilograms (kg)\u002Fmeters squared (m\\^2) (≥23 kg\u002Fm\\^2 for Asian participants).\n\nKey Exclusion Criteria:\n\n* Chronic liver diseases other than MASH\n* Evidence of cirrhosis on screening liver biopsy\n* Have type 1 diabetes or poorly controlled type 2 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL)\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) or pioglitazone must be on stable dose for at least 6 months prior to Screening\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":21,"type":22},1350,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.",[28],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Fibrosis",[30,31,32,33,34,35,36,37,38,39,40,41],"Liver Diseases","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Steatohepatitis","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2024-03-13",{"date":50,"type":22},"2029-02",{"name":52,"class":53},"89bio, Inc.","INDUSTRY",361,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100053934","phase-3-evaluation-of-sonelokimab-in-patients-with-active-psoriatic-arthritis-and-anti-tnf-inadequate-response-100053934","NCT06641089","Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response","A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors","IZAR-2","Inclusion Criteria:\n\n1. Participants must be ≥18 years of age .\n2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.\n3. Participants have active disease (defined by a 68 tender joint count \\[TJC68\\] of ≥3 and a 66 swollen joint count \\[SJC66\\] of ≥3).\n4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.\n5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.\n6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety\u002Ftolerability problems after ≥1 administration of a TNFα inhibitor.\n\nExclusion Criteria:\n\n1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.\n2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.\n3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.\n4. Participants with a diagnosis of inflammatory bowel disease.\n5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.\n6. Participants who have an established diagnosis of arthritis mutilans.\n7. Previous exposure to sonelokimab.\n8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα",{"count":64,"type":22},600,[25],"This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.",[68],"Arthritis, Psoriatic",{"date":45,"type":46},{"date":71,"type":46},"2024-10-15",{"date":73,"type":22},"2027-01-15",{"name":75,"class":53},"MoonLake Immunotherapeutics AG",139,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.","75 Years",{"count":87,"type":22},256,[25],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[91],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":45,"type":46},{"date":94,"type":46},"2025-02-10",{"date":96,"type":22},"2030-12-31",{"name":98,"class":53},"Dianthus Therapeutics",180,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100053964","phase-1-a-phase-i-dose-escalation-and-dose-expansion-study-to-investigate-the-pharmacokinetics-and-safety-of-subcutaneous-durvalumab-100053964","NCT07391670","A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab","A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours","IMFINZI-subQ","Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of ≥ 12 weeks at enrolment.\n* Adequate organ and marrow function.\n* Minimum body weight \\> 30 kg.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).\n* Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.\n* Have not progressed following definitive concurrent chemoradiation.\n\nLS-SCLC Participants -\n\n* Histologically or cytologically documented LS-SCLC (Stage I-III).\n* Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment.\n* Have not progressed following definitive concurrent chemoradiation.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Unresectable HCC based on histopathological confirmation.\n* No prior systemic therapy for unresectable HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC.\n* Child-Pugh Score class A.\n* Measurable disease as defined by RECIST v1.1.\n\nExclusion Criteria:\n\n* Active or prior documented autoimmune disease requiring systemic treatment.\n* Uncontrolled infection (including human immunodeficiency virus \\[HIV\\], hepatitis B or C).\n* Prior exposure to immune checkpoint inhibitors.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Active pneumonitis or interstitial lung disease requiring systemic therapy.\n\nLS SCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Extensive-stage disease.\n* History of Grade ≥ 2 pneumonitis.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Hepatic encephalopathy.\n* Uncontrolled ascites.\n* Active gastrointestinal (GI) bleeding.",{"count":109,"type":22},40,[111],"PHASE1","The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).",[114],"Solid Tumours",[116,117,118,119,120,121,122,123,124,125],"Pharmacokinetics","Non-small cell lung cancer (Stage III, unresectable)","Small cell lung cancer (Limited stage)","Hepatocellular carcinoma (Unresectable)","Subcutaneous","Human hyaluronidase","Monoclonal antibody","Programmed cell death ligand 1 (PD-L1)","Programmed cell death protein 1","Anticancer therapy",{"date":45,"type":46},{"date":128,"type":46},"2026-03-31",{"date":130,"type":22},"2027-08-30",{"name":132,"class":53},"AstraZeneca",19,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":19,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years",{"count":143,"type":22},1200,[25],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[147],"Crohn's Disease",{"date":45,"type":46},{"date":150,"type":46},"2024-06-05",{"date":152,"type":22},"2029-11-12",{"name":154,"class":53},"Merck Sharp & Dohme LLC",499,{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100054176","phase-1-study-of-aro-dimerpa-in-adult-participants-with-mixed-hyperlipidemia-100054176","NCT07223658","Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia","Phase 1\u002F2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia","Inclusion Criteria:\n\n* Willing to follow diet counseling as per Investigator judgment based on local standard of care\n* Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening\n* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later\n\nExclusion Criteria:\n\n* Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA\n* Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy\n* Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)\n* Uncontrolled hypertension\n* History of bleeding diathesis or coagulopathy\n* Current diagnosis of nephrotic syndrome\n\nNote: Additional inclusion\u002Fexclusion criteria may apply per protocol.",{"count":164,"type":22},78,[111,166],"PHASE2","Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.",[169],"Hyperlipidemia; Mixed",{"date":45,"type":46},{"date":172,"type":46},"2025-12-22",{"date":174,"type":22},"2027-07",{"name":176,"class":53},"Arrowhead Pharmaceuticals",15,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":133},"100053987","phase-2-study-to-evaluate-the-pharmacodynamics-safety-and-efficacy-of-sky-0515-in-participants-with-huntingtons-disease-100053987","NCT07378644","Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","A Phase 2\u002F3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","FALCON-HD","Inclusion Criteria:\n\n* 25 years or older.\n* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).\n* Total Functional Capacity (TFC) score of 10 or more).\n* Total Motor Score (TMS) of 6 or more).\n* Independence Score (IS) of 70 or more).\n* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.\n* Men must agree to use birth control during the study and for 90 days after the last dose.\n* Agree to sign a consent form and follow the study's rules and schedule.\n\nExclusion Criteria:\n\n* Other Serious health problems or brain\u002Fspinal issues that could interfere with the study or make procedures unsafe.\n* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.\n* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.\n* Severe allergies or have reacted badly to similar drugs in the past.\n* Taking medications or treatments that might interfere with the study.\n* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).\n* Any kind of gene therapy.\n* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.\n* Liver function tests show significant abnormalities.\n* Positive for hepatitis B, hepatitis C, or HIV.\n* Pregnancy, breastfeeding, or planning to become pregnant during the study.","25 Years",{"count":188,"type":22},400,[166,25],"The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.",[192],"Huntington Disease",[194,195,196,197,192,198,199,200],"SKY-0515","Skyhawk","HTT","Neurodegenerative","mRNA","Splicing","Mutant Huntingtin protein","2026-07-09",{"date":45,"type":46},{"date":204,"type":46},"2026-01-06",{"date":206,"type":22},"2029-08",{"name":208,"class":53},"Skyhawk Therapeutics, Inc.",{"id":210,"slug":4,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":190,"conditions":213,"keywords":214,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":220,"locationsCount":221},"100622055",{"count":188,"type":22},[166,25],[192],[194,195,196,197,192,198,199,200],"2026-06-30",{"date":217,"type":46},"2026-07-01",{"date":204,"type":46},{"date":206,"type":22},{"name":208,"class":53},10,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":19,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100607159","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-100607159","NCT07184931","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","STARSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)\n\nExclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) or indeterminate colitis\n* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapy prior to baseline\n* Participants receiving prohibited medications or therapies\n* Participants with previous exposure to anti-TL1A investigational therapy\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":231,"type":22},980,[25],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Up to 5-week Screening Period.\n* 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction).\n* 12-week Sub-Study 3 (Extended Induction for non-responders).\n* 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.\n\nThe number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.",[147],{"date":217,"type":46},{"date":237,"type":46},"2025-10-01",{"date":239,"type":22},"2029-05-14",{"name":241,"class":53},"Sanofi",301,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100570828","phase-2-safety-efficacy-and-pharmacokinetics-of-bnt327-in-combination-with-chemotherapy-and-other-investigational-agents-for-lung-cancer-100570828","NCT06712316","Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer","A Phase II\u002FIII, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer","Key Inclusion Criteria:\n\n* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer\u002FAmerican Joint Committee on Cancer staging system, 9th edition.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Adequate organ function.\n\nKey Exclusion Criteria:\n\n* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.\n* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:\n\n  * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant\u002Fadjuvant or locally advanced\u002Fmetastatic setting.\n  * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1\u002FVEGF bispecific antibody\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.\n* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing fistula\u002Fperforation.\n* Participants with significant risk of hemorrhage (per investigator clinical judgment).\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":251,"type":22},1260,[166,25],"This is a Phase 2\u002F3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).\n\nThis study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.",[255],"Non-small Cell Lung Cancer",[257,258,259,260,261,262,263,264],"First-line treatment","Combination with chemotherapy","Combination with other investigational agents","Bispecific antibody","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor (VEGF) A","Immunotherapy","Programmed Death-1 monoclonal antibodies",{"date":217,"type":46},{"date":267,"type":46},"2025-01-07",{"date":269,"type":22},"2030-03",{"name":271,"class":53},"BioNTech SE",261,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100614842","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-standard-of-care-chemotherapy-and-bevacizumab-with-or-without-inca33890-in-the-first-line-treatment-of-metastatic-microsatellite-stable-colorectal-cancer-100614842","NCT07284849","A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","Inclusion Criteria:\n\n* Stage IV colorectal adenocarcinoma not amenable to curative resection.\n* No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Adequate organ function determined by laboratory results.\n\nExclusion Criteria:\n\n* MSI-H\u002FdMMR per historical data in the medical record.\n* BRAF V600E mutation per historical data in the medical record.\n* Untreated and\u002For progressing CNS metastases.\n* History of other malignancy within 2 years.\n* Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* Significant concurrent and\u002For uncontrolled medical condition.\n* History of organ transplant, including allogeneic stem cell transplantation.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":281,"type":22},700,[25],"The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.",[285],"CRC (Colorectal Cancer)",[287,288,289],"Metastatic Colorectal Cancer","Colon Cancer","INCA33890","2026-06-29",{"date":215,"type":46},{"date":293,"type":46},"2026-03-05",{"date":295,"type":22},"2029-09-28",{"name":297,"class":53},"Incyte Corporation",275,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":109},"100547974","phase-2-safety-and-efficacy-of-3-dose-levels-of-nmd670-in-adult-patients-with-myasthenia-gravis-100547974","NCT06414954","Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR\u002FMuSK-Ab+ Myasthenia Gravis","SYNAPSE-MG","Inclusion Criteria:\n\n* Participant must be a male or female being 18 or more, at the time of signing the informed consent\n* Diagnosis of MG, MGFA class II, III or IV\n* Documented positive AChR or MuSK antibody test.\n* Participant must be able to swallow tablets\n* Body mass index between 18 and 35 kg\u002Fm2, inclusive, at screening, and with a minimum weight of 40 kg\n* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Participant is capable of and has given signed informed consent\n\nExclusion Criteria:\n\n* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study\n* Participants with other significant clinical and\u002For laboratory safety findings that may interfere with the conduction or interpretation of the study\n* Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1\n* Participants with history of poor compliance with relevant MG therapy\n* Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding",{"count":308,"type":22},84,[166],"This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.",[312,313],"Myasthenia Gravis","Myasthenia Gravis, MuSK",{"date":217,"type":46},{"date":316,"type":46},"2024-05-16",{"date":318,"type":22},"2026-12",{"name":320,"class":53},"NMD Pharma A\u002FS",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":328,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"100588709","phase-1-a-study-of-bbt002-in-healthy-volunteers-hvs-and-in-adult-patients-with-chronic-obstructive-pulmonary-disease-copd-or-chronic-rhiosininusitis-with-nasal-polyps-crswnp-100588709","NCT06944925","A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)","A Randomized, Double-Blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Patients With COPD or CRSwNP","Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)\n\n1. Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)\n2. Body mass index between 18.0-32.0 kg\u002Fm square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg\u002Fm square, capped weight at 125kg for patients (Parts C, D, F, and G)\n3. Negative pregnancy tests for women of childbearing potential\n4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit\n5. Non-smokers, healthy current smokers (≤5 cigarettes\u002Fday), or ex-smokers\n6. Adequate contraception use (for men and women of childbearing potential)\n7. No clinically significant abnormalities or history of relevant diseases\n\nKey Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second\u002FForced Vital Capacity less than 0.70\n\nKey Inclusion Criteria (Parts D and G)\n\n1\\. Participants with confirmed diagnosis of CRSwNP\n\nKey Exclusion Criteria for (Parts A, B, C, D, E, F, and G)\n\n1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)\n2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections\n3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders\n4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function\n5. Positive drug\u002Falcohol tests or abnormal vital signs at screening or Day -1\n6. Abnormal Electrocardiogram(ECG) findings\n7. History of drug\u002Falcohol abuse in the past 2 years\n8. History of severe allergic reactions or hypersensitivity\n\nKey Exclusion Criteria (Part C and F only)\n\n1. Current diagnosis of other significant pulmonary disease\n2. Significant or unstable cardiovascular diseases\n3. Recent clinically significant infection\n4. Inability to perform spirometry\n\nKey Exclusion Criteria (Parts D and G)\n\n1. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP\n2. Sinonasal surgery (recent\u002Fextensiv)\n3. Consitions interfering with nasal assessments\n4. Excluded sinonasal\u002Fsystemic diseases",true,{"count":330,"type":22},286,[111],"Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).",[334],"Chronic Obstructive Pulmonary Disease","2026-06-28",{"date":217,"type":46},{"date":338,"type":46},"2025-05-08",{"date":340,"type":22},"2027-07-31",{"name":342,"class":53},"Bambusa Therapeutics",14,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":359,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100629270","phase-2-a-phase-23-study-on-the-efficacy-and-safety-of-mangaciclanol-for-contrast-enhanced-mri-of-cns-or-body-in-adult-patients-100629270","NCT07472491","A Phase 2\u002F3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients","A Prospective, Multicenter Phase 2\u002F3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)","LUMINA","Inclusion Criteria:\n\n* The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.\n* The participant is able and willing to comply with study procedures as described in the protocol.\n* The participant has read, understood, signed and dated the ICF prior to any study procedures.\n* Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for contrast-enhancing MRI of the CNS. The suspicion may be based on a previous imaging procedure such as computed tomography (CT), positron emission tomography (PET)\u002FCT or MRI performed within 12 months prior to ICF signature.\n* Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax, abdomen, pelvis, and musculoskeletal system \\[only breast in the United States in compliance with local approved indications of gadobutrol\\]) referred as part of standard care for contrast-enhancing MRI of the body. The suspicion may be based on a previous imaging procedure such as CT, PET\u002FCT, ultrasound or MRI performed within 12 months prior to ICF signature.\n* The participant is scheduled for a contrast-enhanced MRI examination of the CNS or a body region for clinical reasons and has agreed to have a second contrast-enhanced MRI examination for the purpose of this study.\n* The participant is in a clinically stable condition (i.e., no acute deterioration within 48 hours before enrollment).\n* Female Participants: The participant is a female who is either surgically sterile (has had a documented bilateral oophorectomy, bilateral salpingectomy, and\u002For documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum human chorionic gonadotropin pregnancy test, performed at screening and the results of a urine pregnancy test, or serum human chorionic gonadotropin pregnancy test performed prior to each administration of IMP (with the result known before IMP administration), must be negative. Female participants of childbearing potential must agree to use adequate contraception and not harvest or donate eggs from screening until 30 days after final dose of IMP. Such methods include hormonal contraception including oral, intravaginal, transdermal, injectable, and implantable contraceptives; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner. Total abstinence, in accordance with the lifestyle of the participant, is also acceptable.\n* Male Participants: The participant is a male who is surgically sterile (vasectomy or bilateral orchidectomy), a male who is sexually active with a partner who is not of childbearing potential, or a male who is sexually active with a partner of childbearing potential who must agree to use adequate contraception and not harvest or donate sperm from screening until 90 days after final dose of IMP. Adequate contraception for the male participant (and any female partner, if she is of childbearing potential) is defined as using hormonal contraception (including oral, intravaginal, transdermal, injectable or implantable contraceptives), an intrauterine device, or an intrauterine hormone-releasing system, combined with at least one of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the participant, is also acceptable.\n\nExclusion Criteria:\n\n* The participant has previously enrolled in this mangaciclanol study, including participation in an earlier phase or cohort.\n* The participant has a contraindication to MRI examination, such as the presence of a cardiac pacemaker or other electronic devices, presence of ferromagnetic metal foreign bodies in vulnerable positions or within positions that would affect the imaged field of view, presence of certain tattoos that may raise a safety concern for MRI, participant suffering from severe claustrophobia which is not manageable with standard sedation, or participant working as a machinist, welder or metal worker (unless the participant will undergo thorough screening by radiology personnel to rule out the presence of metallic foreign bodies, especially in or near the eyes).\n* Participant with severe cardiovascular disease (e.g., known long QT syndrome including QTc prolongation based on screening ECG, acute myocardial infarction within the past 14 days, unstable angina, congestive heart failure class III\u002FIV by New York Heart Association classification, or acute stroke within the past 48 hours).\n* (Phase 2 only) Participant with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) within 14 days prior to the first IMP administration.\n* (Phase 3 only) Participant with an eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 calculated using the CKD-EPI within 14 days prior to the first IMP administration.\n* Participant with increased likelihood of hypersensitivity specifically to mangaciclanol, gadolinium or a component of the formulation.\n* Participant has received any non-study contrast agent within 72 hours prior to the first study MRI, or is planning to receive any non-study contrast agent during the trial until 24 ± 4 hours after the second study MRI.\n* Participant has received any investigational product within 30 days or within 5 times the half-life of that drug, whichever is shorter, prior to or concurrent with this study.\n* Participant is expected\u002Fscheduled to have any treatment or medical procedure (e.g., chemotherapy, radiotherapy, biopsy, resection, etc.) that may impact aspects of the imaged lesions from the first study MRI up to 24 hours after the second study MRI. (Participants under corticosteroids and\u002For maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).\n* Participant may not be able to complete the study, based on their anticipated life expectancy, or where study participation may compromise the management of the participant, or any other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study.\n* Participant is pregnant or planning to become pregnant, or breast-feeding.\n* Participant is unable or unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and\u002For considered unlikely to complete the trial.",{"count":353,"type":22},640,[166,25],"This is an operationally combined Phase 2\u002F3 study, which will be conducted and evaluated in 2 distinct parts:\n\n* Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.\n* Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body.\n\nThe investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).\n\nPrimary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.",[357,358],"Known or Highly Suspected Central Nervous System (CNS) Lesion","Known or Highly Suspected Body (Excluding CNS) Lesion",[360,361,362,363],"Contrast-enhanced magnetic resonance imaging (MRI)","Mn-based contrast agents (MBCAs)","Gd-based contrast agents (GBCAs)","Lesion visualization","2026-06-26",{"date":290,"type":46},{"date":367,"type":46},"2026-04-01",{"date":369,"type":22},"2027-11-30",{"name":371,"class":53},"GE Healthcare",7,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":382,"type":22},645,[166],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[386,387,388,389],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":290,"type":46},{"date":392,"type":46},"2025-05-27",{"date":394,"type":22},"2028-03",{"name":396,"class":53},"Spyre Therapeutics, Inc.",243,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"100450615","the-conform-pivotal-trial-100450615","NCT05147792","The CONFORM Pivotal Trial","An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion","Inclusion Criteria:\n\n1. Male or non-pregnant female aged ≥18 years\n2. Documented non-valvular AF (paroxysmal, persistent, or permanent)\n3. High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3\n4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation\n5. Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.\n6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care\n7. Able to comply with the protocol-specified medication regimen and follow-up evaluations\n8. The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)\u002FRegional Ethics Board (REB)\u002FEthics Committee (EC).\n\nExclusion Criteria:\n\n1. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.\n2. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO\u002FASD closure device, history of surgical ASD repair or history of surgical LAAO closure)\n3. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)\n4. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)\n5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and\u002For anticoagulant therapy is contraindicated\n6. Documented active systemic infection\n7. Symptomatic carotid artery disease (defined as \\>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \\\u003C50% stenosis noted at the site of prior treatment\n8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure\n9. Recent (within 30 days of index procedure) stroke or transient ischemic attack\n10. Recent (within 30 days of index procedure) myocardial infarction\n11. Vascular access precluding delivery of implant with catheter-based system\n12. Severe heart failure (New York Heart Association Class IV)\n13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant\n14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 (by the Modification of Diet in Renal Disease equation)\n15. Platelet count \\\u003C75,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3, or white blood cell count \\\u003C3,000 cells\u002Fmm3\n16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that cannot be adequately pre-medicated\n17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial\n18. Unable to undergo general anesthesia\n19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years\n20. A condition which precludes adequate transesophageal echocardiographic assessment\n\nEcho exclusion criteria:\n\n1. Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)\n2. Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE\n3. Left ventricular ejection fraction (LVEF) \\\u003C30%\n4. Moderate or large pericardial effusion \\>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology\n5. Atrial septal defect that warrants closure\n6. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \\>15 mm or length \\> 15 mm) or large shunt (early \\[within 3 beats\\] and\u002For substantial passage of bubbles, e.g., \\>20)\n7. Moderate or severe mitral valve stenosis (mitral valve area \\\u003C1.5 cm2)\n8. Complex atheroma with mobile plaque of the descending aorta and\u002For aortic arch\n9. Evidence of cardiac tumor",{"count":406,"type":22},1600,[408],"NA","The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.",[411,412],"Atrial Fibrillation","Stroke",{"date":290,"type":46},{"date":415,"type":46},"2022-05-26",{"date":417,"type":22},"2031-12",{"name":419,"class":53},"Conformal Medical, Inc",92,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":448},"100398026","phase-3-a-study-of-epx-100-clemizole-hydrochloride-in-participants-with-dravet-syndrome-100398026","NCT04462770","A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome","A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)","ARGUS","Key Inclusion Criteria:\n\n1. Male and female participants 2 years and older at time of consent.\n2. Participant or parent\u002Flegally authorized representative (LAR) willing and able to provide written informed consent and assent (if applicable) prior to initiation of any study related procedures.\n3. Clinical diagnosis of DS. Participants must have seizures which are not completely controlled by AEDs with the following criteria:\n\n   * Onset of seizures prior to 18 months of age,\n   * Normal development at onset,\n   * History of at least one type of countable motor seizure (CMS),\n   * Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of DS),\n   * Genetic mutation of the SCN1A gene must be documented.\n\nKey Exclusion Criteria:\n\n1. Known sensitivity, allergy, or previous exposure to clemizole HCl.\n2. Exposure to any investigational drug or device \\\u003C90 days prior to screening or plans to participate in another drug or device trial at any time during the study.\n3. Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol \\[THC\\] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.\n4. Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.\n5. Concurrent use of fenfluramine.\n6. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.","2 Years",{"count":431,"type":22},150,[25],"This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).",[435],"Dravet Syndrome",[437,438,439,440],"Clemizole hydrochloride","Convulsive seizure","Pediatric epilepsy","Dravet syndrome",{"date":215,"type":46},{"date":443,"type":46},"2020-09-15",{"date":445,"type":22},"2029-05",{"name":447,"class":53},"Epygenix",60,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":470},"100567400","phase-3-a-clinical-study-of-molnupiravir-to-prevent-severe-illness-from-coronavirus-disease-2019-covid-19-in-people-who-are-high-risk-mk-4482-023-100567400","NCT06667700","A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)","A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression","MOVe-NOW","Inclusion Criteria\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is an individual of any sex\u002Fgender, ≥18 years of age\n* Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization\n* Has initial onset of signs\u002Fsymptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs\u002Fsymptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever \\>38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache\n* Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:\n\n  * Advanced age of ≥75 years of age\n  * Immunocompromised\n  * Neurocognitive or physical disability\n  * Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes)\n* Is unable or unwilling to receive treatment with nirmatrelvir\u002Fritonavir (NMV\u002Fr) due to 1 or more of the following:\n\n  * Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and\u002For life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible\n  * Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance\n  * Has severe hepatic impairment\n  * Has experienced prior adverse reactions or hepatotoxicity to NMV\u002Fr that would preclude future use\n  * Has known or suspected NMV\u002Fr resistance\n  * Has uncontrolled HIV infection\n  * NMV\u002Fr is not approved\u002Fauthorized in the participant's country or it is not accessible to participant (e.g., drug shortage)\n  * Is unwilling to receive treatment with NMV\u002Fr\n\nInclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study.\n\nExclusion Criteria\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently\n* Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)\n* Has ≥1 of the following signs\u002Fsymptoms that are attributable to severe or critical COVID-19:\n\n  * Shortness of breath at rest\n  * Respiratory rate ≥30 breaths per minute\n  * Heart rate ≥125 beats per minute\n  * Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs\u002Fsymptoms\n  * New or increasing need for supplemental oxygen: receiving \\>4 liters\u002Fminute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19\n* Has received a COVID-19 vaccine within 30 days prior to randomization\n* Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization\n* Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir",{"count":458,"type":22},3082,[25],"Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect.\n\nMolnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.",[462],"Coronavirus Disease (COVID-19)","2026-06-25",{"date":364,"type":46},{"date":466,"type":46},"2024-12-02",{"date":468,"type":22},"2031-01-26",{"name":154,"class":53},224,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100551707","phase-3-efficacy-and-safety-of-a-new-formulation-of-oral-cladribine-compared-with-placebo-in-participants-with-generalized-myasthenia-gravis-myclad-100551707","NCT06463587","Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)","Inclusion Criteria:\n\n* Adults of ≥ 18 years of age at the time of signing the informed consent.\n* Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to IVa classification.\n\n  * In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody(anti-MuSK)\n  * In participants that are autoantibody seronegative i.e. not positive for anti-AChR and anti-MuSK antibodies and participants who are positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4)\n* Has a Screening and Baseline MG-ADL score more than or equal to (\\>=) 6 with \\>= 50 percentage (%) of the total score due to non-ocular symptoms. Screening and Baseline MG-ADL scores must be stable. The difference between the Screening and Baseline scores should not be more than 2 and there should be no reported MG exacerbation during the Screening period\n* If treated with oral corticosteroids: should be on a stable daily dose for at least 3 months prior to and during screening. In such case, the daily dose of oral steroids should not exceed 20 milligrams(mg)\u002Fday for prednisone\u002F prednisolone, 16 mg\u002Fday for methylprednisolone, 3 mg\u002Fday for dexamethasone, or 80 mg for hydrocortisone or equivalent doses for other corticosteroids.\n* If treated with acetylcholinesterase inhibitor should be on a stable daily dose (pyridostigmine dose ≤ 480 mg\u002Fday or neostigmine ≤ 300 mg\u002Fday) for at least 3 months prior to and during screening\n* Have a body weight \\>= 40 kilograms\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Immunologic disorder other than MG or any other condition requiring chronic oral, intravenous, intramuscular, or intraarticular corticosteroid therapy. Well-controlled thyroid disease, as per the Treating Investigator or the participants regular treating physician recorded in the source documents, is not exclusionary\n* Molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or any other neurologic or systematic disease that mimics MG muscular weakness\n* Active, clinically significant viral, bacterial, or fungal infection, including brain MRI or chest X-ray findings consistent with signs of infection such as PML or TB, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 8 weeks prior or during Screening, or completion of oral anti-infectives within 8 weeks prior or during Screening. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary\n* Has a history of or current diagnosis of active tuberculosis (TB) or is currently undergoing treatment for latent TB infection or has an untreated latent TB infection as determined by documented results within 3 months of the Screening Visit of a positive TB skin test .\n* Active malignancy, or history of cancer or signs of malignancy in any Screening assessment\n* Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within 4 weeks prior to randomization\n* Treatment with FcRn or complement inhibitors (such as eculizumab, rozanolixizumab efgartigimod, ravulizumab, zilucoplan or nipocalimab) within 8 weeks prior to randomization\n* History of thymectomy within 6 months prior to Screening.\n* History of generalized seizures (except for history of febrile seizures during the participant's childhood).\n* Negative or indeterminate for Varicella Zoster Virus antibodies at screening\n* History of myasthenic crisis in the last 12 months prior to and during screening\n* History of recurrent infections (that is 3 or more infections per year documented in available source data) within the last 2 years\n* Discontinuation of treatment with any non-steroidal immunosuppressants used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within the last 6 months prior to Screening\n* If treated with non-steroidal immunosuppressants for gMG, the dose at Screening higher than 50 mg\u002Fday for azathioprine, 500 mg\u002Fday for mycophenolate mofetil, 1 mg\u002Fday for tacrolimus, 50 mg\u002Fday for cyclosporine, 25 mg\u002Fday for cyclophosphamide, or 7.5 mg\u002Fweek for methotrexate\n* Participation in clinical study of any investigational drug within 6 months, or 5 half-lives of the investigational drug used in the previous clinical study prior to randomization, whichever is longer. However, participants with any prior exposure to cladribine may not enter the study regardless of timing of exposure\n* Other protocol defined exclusion criteria could apply",{"count":479,"type":22},264,[25],"The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.",[483],"Generalized Myasthenia Gravis",[485,486,487,488],"Anti-AChR antibody positive","anti-MuSK antibody positive","anti-LRP4 antibody positive","seronegative gMG",{"date":290,"type":46},{"date":491,"type":46},"2024-06-25",{"date":493,"type":22},"2030-11-12",{"name":495,"class":53},"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany",144,{"id":498,"slug":4,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":141,"maxAge":19,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":145,"conditions":501,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":505,"locationsCount":155},"100549191",{"count":143,"type":22},[25],[147],{"date":290,"type":46},{"date":150,"type":46},{"date":152,"type":22},{"name":154,"class":53},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":529},"100606299","phase-3-rosetta-breast-01-the-effects-and-safety-of-pumitamig-in-patients-with-triple-negative-breast-cancer-100606299","NCT07173751","ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer","A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease","Inclusion Criteria:\n\n* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.\n* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and\u002For progesterone receptor \\[PgR\\]) 1% to 10%, HER2 immunohistochemistry \\[IHC\\] 0, 1+, or 2+ with fluorescence in situ hybridization \\[FISH\\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n* Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Have received any of the following therapies or drugs prior to the initiation of trial:\n\n  * Have received prior systemic anticancer therapy for advanced disease.\n  * Have received prior treatment with a PD(L)-1\u002Fvascular endothelial growth factor (VEGF) bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \\[mg\\]\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.\n  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.\n* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.\n* Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.",{"count":514,"type":22},558,[25],"This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.",[518],"Breast Neoplasms",[520,260,261,263,521,259],"Metastatic TNBC","Immunotherapy in combination with chemotherapy","2026-06-24",{"date":463,"type":46},{"date":525,"type":46},"2025-10-30",{"date":527,"type":22},"2030-09",{"name":271,"class":53},143,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":555},"100512446","phase-3-an-adjuvant-endocrine-based-therapy-study-of-camizestrant-azd9833-in-erher2--early-breast-cancer-cambria-2-100512446","NCT05952557","An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+\u002FHER2- Early Breast Cancer (CAMBRIA-2)","CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+\u002FHER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease","CAMBRIA-2","Inclusion Criteria:\n\n* Women and Men; ≥18 years at the time of screening (or per national guidelines)\n* Histologically confirmed ER+\u002FHER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.\n* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.\n* Patients must be randomised within 12 months of definitive breast surgery.\n* Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Inoperable locally advanced or metastatic breast cancer\n* Pathological complete response following treatment with neoadjuvant therapy\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation\n* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance \"\n* Known LVEF \\\u003C50% with heart failure NYHA Grade ≥2.\n* Mean resting QTcF interval \\> 480 ms at screening\n* Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions\n* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)\n* Previous treatment with camizestrant, investigational SERDs\u002Finvestigational ER targeting agents, or fulvestrant\n* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.\n* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-\u002Fperi-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.","130 Years",{"count":540,"type":22},5500,[25],"This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+\u002FHER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.",[544],"Breast Cancer, Early Breast Cancer",[546,547,548],"ER+","HER2-","breast cancer",{"date":463,"type":46},{"date":551,"type":46},"2023-10-05",{"date":553,"type":22},"2037-05-06",{"name":132,"class":53},798,{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":580},"100446799","phase-1-study-of-stk-012-alone-and-with-other-treatments-in-patients-with-advanced-lung-cancer-and-other-cancers-100446799","NCT05098132","Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers","A Phase 1\u002F2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications","SYNERGY-101","Selected Inclusion Criteria:\n\n1. Phase 1: Selected advanced solid tumors\n2. Phase 2:\n\n   * Diagnosis of non-small cell lung cancer (NSCLC).\n   * Stage IV or Stage IIIB\u002FIIIC and not a candidate for definitive treatment.\n   * Non-squamous (NSQ) cell histology.\n   * No prior systemic therapy for advanced\u002Fmetastatic NSQ NSCLC.\n   * Must have a tumor that meets at least one of the following criteria on local testing:\n\n     * PD-L1 negative (TPS \\\u003C1%), OR;\n     * STK11 mutated on tumor tissue or ctDNA\n   * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.\n\nSelected Exclusion Criteria:\n\n2\\. Phase 2:\n\n* Prior immune checkpoint inhibitor (anti-PD\\[L\\]1 and\u002For anti-CTLA-4) treatment\n* Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).\n* Received radiotherapy ≤ 7 days of the first dose of study treatment.\n* Known active central nervous system metastases\n* Any history of carcinomatous meningitis",{"count":565,"type":22},364,[111,166],"This is a phase 1\u002F2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.",[569,570,571,572],"Advanced Solid Tumor","Non Small Cell Lung Cancer","Untreated Advanced NSCLC","1st Line NSCLC",{"date":290,"type":46},{"date":575,"type":46},"2022-01-25",{"date":577,"type":22},"2029-01",{"name":579,"class":53},"Synthekine",47,{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":595,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":604},"100631162","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-systemic-sclerosis-100631162","NCT07497087","A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)","VERANDA™-SSc","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) criteria for SSc.\n3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).\n4. Disease onset (defined by first non-RP \\[Raynaud's phenomenon\\] symptom) must be within 7 years of Visit 1.\n5. Trial participants with dcSSc must have evidence of active disease during screening.\n6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.\n7. FVC % predicted ≥45% at Visit 1.\n8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.\n9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.\n10. Patients may be either untreated or on stable treatment with permitted immunosuppressive\u002Fimmunomodulatory agents and\u002For nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period\n\nExclusion criteria:\n\n1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.\n2. Any suicidal behaviour in the past 2 years.\n3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.",{"count":590,"type":22},448,[25],"Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day.\n\nParticipants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[594],"Systemic Sclerosis","NOT_YET_RECRUITING","2026-06-23",{"date":522,"type":46},{"date":599,"type":22},"2026-06-22",{"date":601,"type":22},"2030-03-17",{"name":603,"class":53},"Boehringer Ingelheim",233,{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":613,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":634},"100609238","phase-3-study-of-revumenib-in-combination-with-intensive-chemotherapy-in-newly-diagnosed-acute-myeloid-leukemia-aml-with-a-npm1-mutation-100609238","NCT07211958","Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation","REVEAL-ND NPM1","Key Inclusion Criteria:\n\n* Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.\n* Presence of an NPM1 mutation.\n* Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \\>65 years old); Karnofsky or Lansky ≥40.\n* Have a life expectancy of ≥3 months as judged by the Investigator.\n* Negative serum pregnancy test.\n* Adequate liver, kidney, and cardiac function.\n\nKey Exclusion Criteria:\n\n* Diagnosis of active acute promyelocytic leukemia.\n* Active central nervous system disease.\n* Fridericia's corrected QT interval (QTcF) \\>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.\n* Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.\n* Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).\n* Inability to swallow oral medication.\n* Pregnant or nursing females.\n* Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.","12 Years",{"count":615,"type":22},468,[25],"The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.",[619],"Acute Myeloid Leukemias",[621,622,623,619,624,625,626],"SNDX-5613","Nucleophosmin 1","NPM1","AML","Revumenib","Newly diagnosed AML",{"date":522,"type":46},{"date":629,"type":46},"2025-11-25",{"date":631,"type":22},"2031-01",{"name":633,"class":53},"Syndax Pharmaceuticals",52,""]