[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Bulgaria\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":679},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,311,0,25,[9,55,77,107,130,153,178,203,231,263,298,331,358,384,406,435,455,483,505,527,550,578,601,625,655],{"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":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100053313","phase-3-study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-high-risk-patients-with-atrial-fibrillation-who-have-been-deemed-unsuitable-for-oral-anticoagulation-lilac-timi-76-100053313","NCT05712200","Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patient is able to understand and has provided written informed consent to participate in the trial\n* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)\n* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3\n* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study\n* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls\n* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study\n\nExclusion Criteria:\n\n* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)\n* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF\n* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment\n* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization\n* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study\n* Patients on dialysis at screening or who are planned to start dialysis within 6 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","65 Years",{"count":87,"type":22},2500,[25],"A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.",[91],"Atrial Fibrillation (AF)",[93,94,95,96,97,98],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation",{"date":45,"type":46},{"date":101,"type":46},"2022-12-27",{"date":103,"type":22},"2027-12-30",{"name":105,"class":53},"Anthos Therapeutics, Inc.",789,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100053295","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-karxt--karx-ec-for-the-treatment-of-agitation-associated-with-alzheimers-disease-adagio-1-100053295","NCT07011732","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).\n  * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:\n\n    i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.\n  * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n  * AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n  * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).\n\nExclusion Criteria\n\n\\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).\n\nC. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years","90 Years",{"count":117,"type":22},426,[25],"The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.",[121],"Alzheimer Disease",{"date":45,"type":46},{"date":124,"type":46},"2025-07-10",{"date":126,"type":22},"2028-12-08",{"name":128,"class":53},"Bristol-Myers Squibb",158,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"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":140,"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).",[144],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":45,"type":46},{"date":147,"type":46},"2025-02-10",{"date":149,"type":22},"2030-12-31",{"name":151,"class":53},"Dianthus Therapeutics",180,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":138,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100053409","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-pegozafermin-in-participants-with-compensated-cirrhosis-due-to-mash-100053409","NCT06419374","A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).\n* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.\n* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.\n* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \\\u003C50.0 kilograms (kg)\u002Fmeters squared (m\\^2).\n\nKey Exclusion Criteria:\n\n* Liver disorder other than MASH.\n* History or evidence of hepatic decompensation.\n* History or evidence of hepatocellular carcinoma.\n* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL).\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) must be on stable dose for at least 6 months prior to screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply.",{"count":161,"type":22},762,[25],"The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \\[previously known as nonalcoholic steatohepatitis, NASH\\]).",[165],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[167,31,32,33,34,35,168,169,37,38,39,40,41,170],"Liver disease","Nonalcoholic steatohepatitis","NASH","Cirrhosis",{"date":45,"type":46},{"date":173,"type":46},"2024-05-24",{"date":175,"type":22},"2031-08",{"name":52,"class":53},317,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100054279","phase-3-regn7508-versus-apixaban-and-enoxaparin-for-thromboprophylaxis-after-total-knee-arthroplasty-in-adults-100054279","NCT07015905","REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults","A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)","ROXI-APEX","Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n3. Body weight ≤130 kg at screening visit as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol\n3. History of thromboembolic disease or thrombophilia\n4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization\n5. Has an estimated Glomerular Filtration Rate (GFR) of \\\u003C30 mL\u002Fmin\u002F1.73 m2 at the screening visit as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":187,"type":22},2000,[25],"This study is researching an experimental drug called REGN7508 (called \"study drug\"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[191],"Venous Thromboembolism (VTE)",[193,194],"Unilateral Total Knee Arthroplasty (TKA)","Factor XI (FXI)",{"date":45,"type":46},{"date":197,"type":46},"2025-06-25",{"date":199,"type":22},"2027-05-12",{"name":201,"class":53},"Regeneron Pharmaceuticals",46,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100054201","phase-3-a-study-to-evaluate-the-safety-and-effectiveness-of-upadacitinib-tablets-in-adult-and-adolescent-participants-with-severe-alopecia-areata-100054201","NCT06012240","A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata","Up-AA","Inclusion Criteria:\n\n* Adult individuals must be \\\u003C 64 years old at Baseline Visit. Where permitted outside United States (US)\u002FEuropean Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.\n* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \\>= 50 scalp hair loss at Screening and Baseline.\n* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.\n* Current episode of AA of less than 8 years.\n\nExclusion Criteria:\n\n* Current diagnosis of primarily diffuse type of AA.\n* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.\n* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.","12 Years","63 Years",{"count":214,"type":22},1500,[25],"Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.\n\nUpadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.\n\nParticipants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[218],"Alopecia Areata",[218,220,221,222],"Upadacitinib","Rinvoq","ABT-494",{"date":45,"type":46},{"date":225,"type":46},"2023-10-11",{"date":227,"type":22},"2030-04",{"name":229,"class":53},"AbbVie",281,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":242,"conditions":243,"keywords":247,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100054235","phase-3-zilebesiran-in-patients-with-hypertension-not-adequately-controlled-and-with-either-established-cardiovascular-disease-or-high-risk-for-cardiovascular-disease-100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":240,"type":22},11000,[25],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[244,245,246],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[248,249,250,251,252,253,254],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":45,"type":46},{"date":257,"type":46},"2025-09-22",{"date":259,"type":22},"2030-09-30",{"name":261,"class":53},"Alnylam Pharmaceuticals",995,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100053343","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-spt-300-glyphallo-in-participants-with-major-depressive-disorder-with-or-without-anxious-distress-buoy-1-study-100053343","NCT07065240","A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)","A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress","Inclusion Criteria:\n\n* Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.\n* Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.\n* Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.\n* Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.\n* Body mass index (BMI) between 18 to 40 kg\u002Fm2, inclusive.\n* Participant is willing and able to refrain from the use of drugs of abuse.\n\nExclusion Criteria:\n\n* History of, or current presentation consistent with:\n\n  1. any depressive episode with psychotic or catatonic features.\n  2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic\u002Fmixed episode.\n  3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.\n  4. schizophrenia, schizoaffective, or other psychotic disorder.\n  5. obsessive-compulsive disorder.\n  6. any persistent neurocognitive disorder.\n* History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.\n* Psychiatric hospitalization within current depressive episode.\n* Evidence or history of clinically significant diseases which can affect the patients' participation.\n* Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300\u002Fplacebo formulation.\n* Participant has a history of drug or alcohol use disorder.\n* Participants with a positive test for cannabinoids.\n* Clinically significant risk of suicide or harm to self or others.",{"count":271,"type":22},360,[273],"PHASE2","This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.",[276,277],"Major Depressive Disorder (MDD)","Major Depressive Disorder With Anxious Distress",[279,280,281,282,283,284,285,286,287,288],"Major Depressive Disorder","Depressive Disorder","Depression","Anxiety","Mood Disorders","BUOY-1 Study","SPT-300","LYT-300","GlyphAllo","Glyph Allopregnanolone","2026-07-09",{"date":45,"type":46},{"date":292,"type":46},"2025-06-19",{"date":294,"type":22},"2027-03",{"name":296,"class":53},"Seaport Therapeutics",61,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100053289","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-remibrutinib-in-secondary-progressive-multiple-sclerosis-100053289","NCT07225504","A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis","REMASTER","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening\u002Frandomization as listed in the protocol.\n\nOther protocol-defined inclusion\u002Fexclusion critria may apply",{"count":307,"type":22},1275,[25],"The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)",[311],"Secondary Progressive Multiple Sclerosis (SPMS)",[313,314,315,316,317,318,319,320,321,322],"MS","Multiple sclerosis","secondary progressive multiple sclerosis","SPMS","remibrutinib","LOU064","adult","Expanded Disability Status Scale","EDSS","McDonald diagnostic criteria",{"date":45,"type":46},{"date":325,"type":46},"2025-11-11",{"date":327,"type":22},"2034-01-02",{"name":329,"class":53},"Novartis Pharmaceuticals",236,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":338,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100054316","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qmf149-indacaterol-acetatemometasone-furoate-versus-budesonide-in-children-from-6-to-less-than-12-years-of-age-with-asthma-100054316","NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","6 Years","11 Years",{"count":341,"type":22},200,[25],"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[345],"Asthma",[345,347,348,349,350],"Pediatric","Breezhaler","QMF149","Budesonide",{"date":45,"type":46},{"date":353,"type":46},"2023-05-11",{"date":355,"type":22},"2028-05-30",{"name":329,"class":53},63,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":367,"type":22},15100,[25],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[371],"Cardiovascular Disease",[373],"Atherosclerotic Cardiovascular Disease","2026-07-01",{"date":376,"type":46},"2026-07-02",{"date":378,"type":46},"2025-06-04",{"date":380,"type":22},"2029-10-26",{"name":382,"class":53},"AstraZeneca",1365,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":392,"maxAge":19,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100579098","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-and-maintenance-therapy-with-afimkibart-ro7790121-in-participants-with-moderately-to-severely-active-crohns-disease-100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","16 Years",{"count":64,"type":22},[25],"This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[397],"Moderately to Severely Active Crohns Disease",{"date":376,"type":46},{"date":400,"type":46},"2025-03-17",{"date":402,"type":22},"2033-12-31",{"name":404,"class":53},"Hoffmann-La Roche",372,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":414,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":434},"100579031","phase-3-study-of-trastuzumab-deruxtecan-with-bevacizumab-versus-bevacizumab-monotherapy-for-first-line-maintenance-in-her2-expressing-ovarian-cancer-destiny-ovarian01-100579031","NCT06819007","Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)","A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01\u002FENGOT-ov89\u002FGEICO144- O\u002FGOG-3112\u002FAPGOT-OV13)","DO-01","Key Inclusion Criteria:\n\n1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.\n\n   \\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).\n4. Is newly diagnosed FIGO Stage III or IV.\n5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+\u002F2+\u002F1+) guidelines1 by prospective central testing.\n\n   \\*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \\[IHC 3+\u002F2+\u002F1+\\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.\n6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.\n\n   \\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.\n7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.\n8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.\n\nKey Exclusion Criteria:\n\n1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.\n2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.\n3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:\n\n   * HRD negative\n   * HRD positive with SD as best response after platinum\n   * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea\n   * HRD tested, but inconclusive\n   * HRD positive but safety concern (safety concern to be specified).\n4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.\n5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.\n\n   \\*Note: For participants enrolled from the Republic of Korea,\n6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).\n7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.\n8. Evidence of active or ongoing bowel obstruction.\n9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).\n\n   Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n10. Has a corrected QT interval prolongation to \\>480 msec based on average of the Screening triplicate 12-lead ECG.\n11. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.","FEMALE",{"count":416,"type":22},582,[25],"This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+\u002F2+\u002F1+) advanced high-grade epithelial ovarian cancer.",[420],"Ovarian Cancer",[422,423,424,425,426],"Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab",{"date":376,"type":46},{"date":429,"type":46},"2025-03-19",{"date":431,"type":22},"2032-01-31",{"name":433,"class":53},"Daiichi Sankyo",208,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":392,"maxAge":19,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":341},"100561337","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-therapy-with-afimkibart-also-known-as-ro7790121-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100561337","NCT06588855","A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis","Ametrine-2","Inclusion Criteria:\n\n* Confirmed diagnosis of UC\n* Moderately to severely active UC assessed by mMS\n* Bodyweight \\>= 40 kilogram (kg)\n* Up to date with colorectal cancer (CRC) screening performed according to local standards\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced UC therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)\n* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed\n* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy",{"count":444,"type":22},350,[25],"This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).",[448],"Moderately to Severely Active Ulcerative Colitis",{"date":376,"type":46},{"date":451,"type":46},"2024-12-11",{"date":453,"type":22},"2031-01-30",{"name":404,"class":53},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100535501","phase-3-study-of-sotorasib-panitumumab-and-folfiri-versus-folfiri-with-or-without-bevacizumab-awwb-in-treatment-nave-participants-with-metastatic-colorectal-cancer-with-kras-pg12c-mutation-100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":464,"type":22},450,[25],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[468],"Metastatic Colorectal Cancer",[470,471,472,473,474],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":376,"type":46},{"date":477,"type":46},"2024-07-17",{"date":479,"type":22},"2032-04-25",{"name":481,"class":53},"Amgen",292,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100517384","phase-3-a-long-term-study-of-elafibranor-in-adult-participants-with-primary-biliary-cholangitis-100517384","NCT06016842","A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis","A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)","ELFIDENCE","Inclusion Criteria :\n\n* Male or female participants must be ≥18 years of age at the time of signing the informed consent.\n* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)\n* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria :\n\n* History or presence of other concomitant liver disease including but not limited to:\n\n  * i) Primary sclerosing cholangitis (PSC).\n  * ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.\n  * iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.\n  * iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).\n  * v) Alcohol-associated liver disease (ALD).\n  * vi) Nonalcoholic steatohepatitis (NASH).\n  * vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.\n* History or presence of clinically significant hepatic decompensation, including:\n\n  * i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \\>12 due to hepatic impairment.\n  * ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.\n  * iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.\n* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.\n* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).\n* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.\n* Non-hepatic medical conditions that may diminish life expectancy to \\\u003C2 years, including known cancers.\n* History of hepatocellular carcinoma.\n* Alpha-fetoprotein (AFP) \\>20 ng\u002FmL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.\n* Known malignancy or history of malignancy within the last 5 years. Participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to baseline: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).\n* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.\n\n  i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.\n* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \\>450 msec in males or QTcF \\>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \\>480 msec would be exclusionary.\n* Total bilirubin (TB) \\>5x ULN\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>5x ULN at SV1\n* Creatinine phosphokinase (CPK) \\>2x ULN.\n* Platelet count \\\u003C50,000\u002FμL\n* International normalised ratio (INR) \\>1.8 in the absence of anticoagulant therapy.\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.\n* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).\n* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.\n* Participants unwilling or unable to be abstinent from alcohol during the study.\n* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.\n* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).\n* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.\n* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.\n* Alkaline phosphatase (ALP) ≥10x ULN.\n* Albumin \\\u003C2.8 g\u002FdL due to impaired hepatic function.",{"count":492,"type":22},276,[25],"The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).\n\nPBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.\n\nThe liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.\n\nThis study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.\n\nThe main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).\n\nThis study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.",[496],"Primary Biliary Cholangitis (PBC)",{"date":376,"type":46},{"date":499,"type":46},"2023-08-31",{"date":501,"type":22},"2029-05-31",{"name":503,"class":53},"Ipsen",186,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":512,"maxAge":115,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100506775","phase-3-a-study-to-evaluate-the-long-term-safety-of-astegolimab-in-participants-with-chronic-obstructive-pulmonary-disease-copd-100506775","NCT05878769","A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)","A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Completion of the 52-week treatment period in either parent GB43311 or GB44332\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment\n* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study\n* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study\n* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study","40 Years",{"count":187,"type":22},[25],"The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.",[517],"Chronic Obstructive Pulmonary Disease",[519],"chronic obstructive pulmonary disease, COPD",{"date":376,"type":46},{"date":522,"type":46},"2023-06-28",{"date":524,"type":22},"2034-07-01",{"name":404,"class":53},486,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":392,"maxAge":19,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"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":536,"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.",[540],"Crohn's Disease","2026-06-30",{"date":374,"type":46},{"date":544,"type":46},"2025-10-01",{"date":546,"type":22},"2029-05-14",{"name":548,"class":53},"Sanofi",301,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":567,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":574,"leadSponsor":576,"locationsCount":577},"100595823","phase-3-maridebart-cafraglutide-in-heart-failure-with-preserved-or-mildly-reduced-ejection-fraction-and-obesity-100595823","NCT07037459","Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)","MARITIME-HF","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent.\n* BMI ≥ 30.0 kg\u002Fm\\^2 at randomization.\n* HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.\n* Managed with HF standard of care therapies.\n* Left ventricular ejection fraction (LVEF) of \\> 40% within 12 months before randomization.\n\nExclusion Criteria:\n\n* History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.\n* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy\u002Fdysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.\n* Hospitalized with acute decompensated HF at the time of or during the screening period.\n* Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.\n* For participants with a prior diagnosis of T2DM (including those diagnosed during screening):\n\n  1. HbA1c \\> 10.0% (86 mmol\u002Fmol) at screening\n  2. Uncontrolled diabetes requiring immediate therapy\n  3. History of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 12 months before randomization\n  4. One or more episodes of severe hypoglycemia within 6 months before randomization and\u002For history of hypoglycemia unawareness\n  5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and\u002For macular edema.\n* SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \\> 160 mmHg during the screening period (including day 1 prior to randomization).\n* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.\n* Any personal lifetime history of, or family history(first-degree relative\\[s\\]) of medullary thyroid carcinoma or MEN-2.\n* eGFR \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.\n* Calcitonin ≥ 50 ng\u002FL (pg\u002FmL) at screening.\n* Acute or chronic hepatitis.\n* Any of the following psychiatric history:\n\n  1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period\n  2. Lifetime history of suicide attempt\n  3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.\n* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.\n* Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.","99 Years",{"count":560,"type":22},5056,[25],"This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.",[564,565,566],"Heart Failure With Preserved Ejection Fraction","Heart Failure With Mildly Reduced Ejection Fraction","Obesity",[568,566,569,570,571],"Heart Failure","Maridebart Cafraglutide","AMG 133","MariTide",{"date":376,"type":46},{"date":197,"type":46},{"date":575,"type":22},"2030-09-29",{"name":481,"class":53},628,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":591,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":140},"100588118","phase-3-a-study-to-evaluate-the-long-term-efficacy-and-safety-of-karxt--karx-ec-for-agitation-in-alzheimers-disease-adagio-3-100588118","NCT06937229","A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)","Inclusion Criteria:\n\n* Participants must have completed study CN012-0023 or CN012-0024 per protocol.\n* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).\n\nExclusion Criteria:\n\n* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":586,"type":22},650,[25],"The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate\u002Ftrospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.",[121,590],"Agitation",[590,592,593,594],"Alzheimer disease","KarXT","KarX-EC",{"date":374,"type":46},{"date":597,"type":46},"2025-12-02",{"date":599,"type":22},"2029-07-20",{"name":128,"class":53},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100587974","phase-3-a-study-to-learn-about-the-effects-of-felzartamab-infusions-on-adults-with-immunoglobulin-a-nephropathy-igan-100587974","NCT06935357","A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)","PREVAIL","Key Inclusion Criteria:\n\n* Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.\n* An eGFR ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 is acceptable for the cohorts 3 and 4.\n* Proteinuria of ≥ 1.0 gram per day (g\u002Fday) or UPCR ≥0.8 gram per gram (g\u002Fg) as assessed by an adequate 24-hour urine collection.\n* Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and\u002For mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.\n\nKey Exclusion Criteria:\n\n* Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.\n* History of rapidly progressive variant of IgAN, defined as eGFR loss by \\> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.\n* IgAN-(MCD) variant.\n* Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.\n* Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \\> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).\n* Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.\n* Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (\\> 7.5 milligrams per day \\[mg\u002Fd\\] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids \\> 7.5 mg\u002Fday prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.\n* Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.\n* Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.\n* Hypogammaglobulinemia: serum Immunoglobin G (IgG) \\\u003C 6.0 gram per litre (g\u002FL), at Screening.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":610,"type":22},454,[25],"In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.\n\nThe main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:\n\n• How much does the amount of protein in the urine change from the start of the study to Week 36?\n\nResearchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.\n\nThe study will be done as follows:\n\n* Participants will be screened to check if they can join the study.\n* Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.\n* Neither the researchers nor the participants will know what the participants will receive.\n* Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.\n* Afterwards, participants will enter a follow-up period which will last 80 weeks.\n* In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.",[614],"Immunoglobulin A Nephropathy (IgAN)",[616],"Felzartamab",{"date":374,"type":46},{"date":619,"type":46},"2025-05-08",{"date":621,"type":22},"2029-06-05",{"name":623,"class":53},"Biogen",246,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":23,"phases":634,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":654},"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":633,"type":22},1260,[273,25],"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.",[637],"Non-small Cell Lung Cancer",[639,640,641,642,643,644,645,646],"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":374,"type":46},{"date":649,"type":46},"2025-01-07",{"date":651,"type":22},"2030-03",{"name":653,"class":53},"BioNTech SE",261,{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":211,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":663,"briefSummary":664,"conditions":665,"keywords":667,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":671,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":678},"100445243","phase-3-a-study-to-test-the-efficacy-and-safety-of-staccato-alprazolam-in-study-participants-12-years-of-age-and-older-with-stereotypical-prolonged-seizures-100445243","NCT05077904","A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures","A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures","Inclusion Criteria:\n\n* Participant must be ≥12 years of age at the Baseline\u002FRandomization Visit\n* Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; the study caregiver(s) must be able to recognize and observe the participant's seizures\n* Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following:\n\n  1. Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes\n  2. Episodes of a focal seizure with a minimum duration of 3 minutes\n  3. Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized\u002Fbilateral tonic-clonic seizure with a minimum total duration of 3 minutes\n* Prior to the Screening Visit, participant has experienced ≥4 stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have occurred within the 3 months prior to the Screening Visit\n* Participant has had a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of epilepsy and within the 5 years prior to the Screening Visit, that confirms the absence of a progressive neurological disorder\n* Participant is receiving a regimen of antiseizure medications (ASMs) that has been stable (ie, no addition or removal of ASM\\[s\\]; dose adjustments are permitted to ASM\\[s\\]; dose adjustments are not permitted for benzodiazepines) for 30 days prior to the Screening Visit\n* Male and female participants:\n\n  1. A male participant must agree to use contraception during the Outpatient Treatment Period and for at least 7 days after IMP administration and refrain from donating sperm during this period\n  2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the Outpatient Treatment Period and for at least 30 days after IMP administration\n* Participant is capable of giving signed informed consent (or giving assent, where required), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), the protocol, and the individualized participant management plan (iPMP). The ICF or a specific assent form, where required, will be signed and dated by minors\n* The participant's study caregiver(s) must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF, the protocol, and the iPMP\n\nExclusion Criteria:\n\n* Participant has a current history of alcohol or drug use disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year\n* Participant has a known hypersensitivity to any components of the IMP or comparable drugs (and\u002For an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specific requirements)\n* Participant has a diagnosis of atrial fibrillation or mitral stenosis\n* Participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8 weeks prior to the Screening Visit\n* Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures\n* Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and\u002For acute respiratory signs\u002Fsymptoms (eg, shortness of breath, wheezing on lung auscultation)\n* Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases \\[including idiopathic pulmonary fibrosis\\]) and\u002For recent history or presence of hemoptysis or pneumothorax\n* Participant has had a positive antigen test for acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs\u002Fsymptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and\u002For oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to Screening\n* Participant has experienced a upper respiratory tract infection within 4 weeks or bronchitis\u002Fpneumonia within 3 months before the Screening Visit\n* Participant has a history or presence of acute narrow-angle glaucoma\n* Participant has a condition for which oral alprazolam is contraindicated (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)\n* Participant has a history or presence of long QT syndrome, a family history of sudden death due to long QT syndrome, or unexplained syncope\n* Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be allowed for approximately 30 % of study participants\n* Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone\n* Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis\n* Participant is taking nonselective beta blockers on a chronic basis\n* Participant is taking pharmacotherapy for an active major psychiatric disorder where major changes in regimen are needed or anticipated during the study\n* Participant has been treated with vagal nerve stimulation (VNS) for less than 6 months or VNS settings have changed within 30 days before the Screening Visit\n* Participant has a clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, according to the judgment of the Investigator\n* Participant has an oxygen saturation \\\u003C95 % (or less than normal in regions of altitude \\>2500 meters) for greater than 30 seconds during the Screening Visit. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will be excluded\n* Participant has \\>2.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome or \\>2.0xULN total bilirubin for liver impairment)\n* Participant has current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis\n* Participant has a QT interval corrected for heart rate (QTc) \\>450 msec (males), QTc interval \\>470 msec (females), or QTc interval \\>480 msec (participants with bundle branch block), PR interval ≥220 msec, or any other clinically significant electrocardiogram (ECG) abnormality according to the Investigator i) The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF). It is either machine-read or manually over-read\n* Participant has a positive urine screen for drugs of abuse at the Screening Visit\n* Participant has a blood pressure (BP) or heart rate (HR) outside the following range after 5 minutes rest: systolic BP: 90 mmHg to 150 mmHg; diastolic BP: 4 0mmHg to 95 mmHg; HR: 50 bpm to 100 bpm. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will be excluded",{"count":444,"type":22},[25],"The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.",[666],"Stereotypical Prolonged Seizures",[668,669,670],"Stereotypical prolonged seizures","Phase 3","Staccato alprazolam",{"date":374,"type":46},{"date":673,"type":46},"2021-12-07",{"date":675,"type":22},"2026-07-31",{"name":677,"class":53},"UCB Biopharma SRL",183,""]