[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"India\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":648},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,786,0,25,[9,54,76,105,127,150,181,206,237,266,288,317,340,371,387,419,446,467,490,512,540,560,582,613,623],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":20,"type":21},1350,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Fibrosis",[29,30,31,32,33,34,35,36,37,38,39,40],"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":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":45},"2024-03-13",{"date":49,"type":21},"2029-02",{"name":51,"class":52},"89bio, Inc.","INDUSTRY",361,{"id":55,"slug":4,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100054056","NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","12 Years",{"count":62,"type":21},132,[64],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[67],"Proteinuric Kidney Diseases",{"date":44,"type":45},{"date":70,"type":45},"2026-03-23",{"date":72,"type":21},"2028-02-17",{"name":74,"class":52},"Boehringer Ingelheim",161,{"id":77,"slug":4,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"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":85,"type":21},2500,[24],"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.",[89],"Atrial Fibrillation (AF)",[91,92,93,94,95,96],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation",{"date":44,"type":45},{"date":99,"type":45},"2022-12-27",{"date":101,"type":21},"2027-12-30",{"name":103,"class":52},"Anthos Therapeutics, Inc.",789,{"id":106,"slug":4,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"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":114,"type":21},426,[24],"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.",[118],"Alzheimer Disease",{"date":44,"type":45},{"date":121,"type":45},"2025-07-10",{"date":123,"type":21},"2028-12-08",{"name":125,"class":52},"Bristol-Myers Squibb",158,{"id":128,"slug":4,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100054215","NCT05744921","A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works","An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria","ACCESS-EXT","Key Inclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Patients with PNH who have completed, without permanent discontinuation, study treatment in the parent study (R3918-PNH-2021\\[NCT05133531\\]), including the post-Open-label treatment period (OLTP) transition period, if applicable.\n2. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol.\n\nPatients Entering with C5 polymorphism\n\n1. Patients with PNH who have a documented C5 polymorphism rendering them refractory to eculizumab or ravulizumab (eg, p.Arg885His, p.Arg885Cys), as described in the protocol\n2. Diagnosis of PNH confirmed by high-sensitivity flow cytometry testing with PNH granulocytes or monocytes\n3. Active disease, as defined by the presence of 1 or more PNH-related sign or symptom as described in the protocol\n4. LDH level ≥2 × upper limit of normal (ULN) at the screening visit\n5. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol\n\nKey Exclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and\u002For safety of the patient\n2. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study\n\nPatients Entering with C5 polymorphism\n\n1. Prior treatment with complement inhibitors within 5 half-lives of the respective agent prior to screening, except for prior eculizumab or ravulizumab which are not exclusionary\n2. Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplant\n3. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to enrollment and serotype B vaccine within 3 years prior to enrollment as described in the protocol\n4. Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic acid (RNA) during screening\n5. Patients with known HIV with history of opportunistic infections in the last 1 year as described in the protocol\n6. Known hereditary complement deficiency\n7. Documented history of active, uncontrolled, ongoing systemic autoimmune diseases\n8. Documented history of liver cirrhosis or patients with liver disease with evidence of current impaired liver function or patients with elevations in Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (unrelated to PNH or its complications) as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":135,"type":21},202,[24],"This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as \"study drugs\" in this section.\n\nThis study is looking at several other research questions, including:\n\n* How effective is the pozelimab + cemdisiran combination?\n* What side effects may happen from taking the study drugs?\n* How much of each study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)",[139],"Paroxysmal Nocturnal Hemoglobinuria",[141],"PNH",{"date":44,"type":45},{"date":144,"type":45},"2023-03-07",{"date":146,"type":21},"2029-02-26",{"name":148,"class":52},"Regeneron Pharmaceuticals",45,{"id":151,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100053442","NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":158,"type":21},810,[24],"The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[162],"Relapsed or Refractory Multiple Myeloma",[164,165,166,167,168,169,170,171,172],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide",{"date":44,"type":45},{"date":175,"type":45},"2022-09-20",{"date":177,"type":21},"2033-11-30",{"name":179,"class":52},"Celgene",266,{"id":182,"slug":4,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"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.","75 Years",{"count":189,"type":21},762,[24],"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\\]).",[193],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[195,30,31,32,33,34,196,197,36,37,38,39,40,198],"Liver disease","Nonalcoholic steatohepatitis","NASH","Cirrhosis",{"date":44,"type":45},{"date":201,"type":45},"2024-05-24",{"date":203,"type":21},"2031-08",{"name":51,"class":52},317,{"id":207,"slug":4,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":221,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"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":214,"type":21},11000,[24],"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.",[218,219,220],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[222,223,224,225,226,227,228],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":44,"type":45},{"date":231,"type":45},"2025-09-22",{"date":233,"type":21},"2030-09-30",{"name":235,"class":52},"Alnylam Pharmaceuticals",995,{"id":238,"slug":4,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100053717","NCT05755386","Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)","APPARENT","Inclusion Criteria:\n\n* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).\n* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization\n* UPCR ≥ 1.0 g\u002Fg (≥ 113 mg\u002Fmmol) sampled from the first morning void urine sample at Day -75 and Day -15\n* Estimated GFR (using the chronic kidney disease \\[CKD\\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.\n* If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.\n\nExclusion Criteria:\n\n* Participants who have undergone cell or solid organ transplantation, including kidney transplantation.\n* Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:\n* Deposition of antigen-antibody immune complexes as a result of any chronic infections, including\n\n  * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);\n  * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections\n  * Protozoa\u002Fother infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis\n\nRenal deposition of immune complexes as a result of a systemic autoimmune disease:\n\n* Systemic lupus erythematosus (SLE)\n* Sjögren syndrome\n* Rheumatoid arthritis\n* Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n\nFibrillary glomerulonephritis\n\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.\n* Kidney biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.\n* The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.\n* The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.\n* Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.\n* Body mass index (BMI) \\>38 kg\u002Fm2 at screening and randomization. Body weight \\\u003C35 kg at screening and randomization","60 Years",{"count":246,"type":21},106,[24],"This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.",[250],"IC-MPGN",[252,250,253,254,255,256],"LNP023","iptacopan","UPCR","eGFR","proteinuria","2026-07-09",{"date":44,"type":45},{"date":260,"type":45},"2023-10-02",{"date":262,"type":21},"2029-05-31",{"name":264,"class":52},"Novartis Pharmaceuticals",131,{"id":267,"slug":4,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":244,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":287},"100053840","NCT04817618","Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.","APPEAR-C3G","Inclusion Criteria:\n\n* Male and female participants age ≥ 12 and ≤ 60 years at screening.\n* Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.\n* Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.\n* UPCR ≥ 1.0 g\u002Fg sampled from the first morning void urine sample at Day -75 and Day -15.\n* Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.\n* If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.\n\nExclusion Criteria:\n\n* Participants who have received any cell or organ transplantation, including a kidney transplantation.\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.\n* Renal biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%\n* Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration\n* The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.\n* The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar medication) within 90 days of study drug administration.\n* Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.",{"count":274,"type":21},98,[24],"The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.\n\nThe study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.",[278],"C3G",[252,253,278,254,255,256,280],"Quality of life",{"date":44,"type":45},{"date":283,"type":45},"2021-07-28",{"date":285,"type":21},"2027-01-29",{"name":264,"class":52},87,{"id":289,"slug":4,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":295,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":316},"100054167","NCT06240715","Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm","A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth","CORDMILK-PT","Inclusion Criteria:\n\n* Preterm infants born between 30 0\u002F7 weeks to 34 6\u002F7 weeks of gestation\n* Non-vigorous at birth\n\nExclusion Criteria:\n\n* Infants with congenital malformation\n* Major chromosomal abnormalities\n* Complete placental abruption\u002Fcutting through the placenta at the time of delivery\n* Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)\n* Mono-chorionic twins,\n* Twins with no information on amnion\u002Fchorion\n* Multiple gestation \\>2","0 Minutes","10 Minutes",{"count":298,"type":21},800,[300],"NA","The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.",[303,304],"Preterm","Infant Death",[303,306,307],"Umbilical cord milking","Placental transfusion",{"date":44,"type":45},{"date":310,"type":45},"2024-07-01",{"date":312,"type":21},"2027-03-30",{"name":314,"class":315},"Nemours Children's Clinic","OTHER",9,{"id":318,"slug":4,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":339},"100053553","NCT07571005","AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)","AMAZE 3","Key Inclusion Criteria:\n\n* Male or female (sex at birth)\n* Age 18 years or above at the time of signing informed consent\n* Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening\n\nKey Exclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records\n* Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy\n* Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening",{"count":325,"type":21},300,[24],"This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[329,330,331],"Obesity","Overweight","Obstructive Sleep Apnoea",{"date":44,"type":45},{"date":334,"type":45},"2026-05-05",{"date":336,"type":21},"2028-10-04",{"name":338,"class":52},"Novo Nordisk A\u002FS",80,{"id":341,"slug":4,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":370},"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":348,"type":21},1275,[24],"The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)",[352],"Secondary Progressive Multiple Sclerosis (SPMS)",[354,355,356,357,358,359,360,361,362,363],"MS","Multiple sclerosis","secondary progressive multiple sclerosis","SPMS","remibrutinib","LOU064","adult","Expanded Disability Status Scale","EDSS","McDonald diagnostic criteria",{"date":44,"type":45},{"date":366,"type":45},"2025-11-11",{"date":368,"type":21},"2034-01-02",{"name":264,"class":52},236,{"id":372,"slug":4,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},"100054210","NCT07571109","AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)","AMAZE 4",{"count":325,"type":21},[24],"This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[329,330,331],{"date":44,"type":45},{"date":334,"type":45},{"date":384,"type":21},"2028-08-21",{"name":338,"class":52},92,{"id":388,"slug":4,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":409,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100626882","NCT07441408","Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis","An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis","Inclusion Criteria:\n\n\\- Participants must have completed participation in either IM027068 or IM0271015 (defined as receiving study intervention (IMP) until completion of EOT visit).\n\nExclusion Criteria:\n\n* Clinically significant AE that resulted in discontinuation or interruption of IMP (Investigational Medicinal Product) in IM027068 or IM0271015 without reinitiation of IMP.\n* Exhibit symptoms of heart failure at rest.\n* History of lung reduction surgery or lung transplant. Note: Being on the transplantation list is allowed.\n* Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single drug therapy that now requires multi-drug therapy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":394,"type":21},2277,[24],"The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies IM027-068 (for idiopathic pulmonary fibrosis (IPF)) and IM027-1015 (for progressive pulmonary fibrosis (PPF)).",[398],"Pulmonary Fibrosis",[400,401,402,403,404,405,406,407,408],"LPA1 receptor antagonist","Idiopathic pulmonary fibrosis","Progressive pulmonary fibrosis","Long-term extension","IPF","PPF","IM027068","IM0271015","Follow up","NOT_YET_RECRUITING","2026-07-01",{"date":412,"type":45},"2026-07-02",{"date":414,"type":21},"2026-12-16",{"date":416,"type":21},"2030-03-30",{"name":125,"class":52},275,{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":434,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":445},"100620446","NCT07357727","A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)","A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive","MANIFEST-3","Key Inclusion Criteria:\n\n* Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022\n* DIPSS risk category of intermediate-1, intermediate-2 or high-risk\n* Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available)\n* Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation)\n* Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2\n* Blasts \\\u003C5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening\n* Platelet count ≥ 100 x 10\\^9\u002FL in the absence of growth factors or transfusions for the previous 4 weeks\n\nKey Exclusion Criteria:\n\n* Prior splenectomy at any time or splenic irradiation in the previous 6 months\n* Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization\n* Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation\n* History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment\n* Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer\n* Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":427,"type":21},460,[24],"The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.",[431,432,433],"Primary Myelofibrosis (PMF)","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-essential Thrombocythemia Myelofibrosis (PET-MF)",[435,436,437,438],"Pelabresib (DAK539)","Ruxolitinib","Adult participants","Myelofibrosis (MF)",{"date":412,"type":45},{"date":441,"type":45},"2026-05-27",{"date":443,"type":21},"2030-12-27",{"name":264,"class":52},20,{"id":447,"slug":4,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":455},"100609217","NCT07211685","A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome","A Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 2a Study With an Extension Phase to Evaluate the Efficacy and Safety of BAY 3401016 in Participants Aged 18 to 45 With Alport Syndrome","ASSESS","Inclusion Criteria:\n\n* Participants must be 18 to 45 years of age inclusive\n* Participants with AS, either XLAS (male) or ARAS (male or female)\n* eGFR ≥ 45 mL\u002Fmin\u002F1.73m2\n* UACR ≥ 500mg\u002Fg\n\nExclusion Criteria:\n\n* Chronic kidney disease is different from AS\n* Clinically significant illness that could have influence on the safety of the participant and\u002For interfere with the study objectives\n* History or current existence of malignancy\n* Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids or urticaria\n* Participants with active skin disorders (e.g. atopic dermatitis, severe acne)\n* Systolic blood pressure above 140 mmHg\n* Diastolic blood pressure above 90 mmHg","45 Years",{"count":455,"type":21},60,[64],"Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS.\n\nThe main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS.",[459],"Alport Syndrome",{"date":412,"type":45},{"date":462,"type":45},"2025-11-19",{"date":464,"type":21},"2028-07-27",{"name":466,"class":52},"Bayer",{"id":468,"slug":4,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":489},"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":475,"type":21},15100,[24],"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.",[479],"Cardiovascular Disease",[481],"Atherosclerotic Cardiovascular Disease",{"date":412,"type":45},{"date":484,"type":45},"2025-06-04",{"date":486,"type":21},"2029-10-26",{"name":488,"class":52},"AstraZeneca",1365,{"id":491,"slug":4,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":16,"minAge":497,"maxAge":18,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":511},"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":499,"type":21},600,[24],"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).",[503],"Moderately to Severely Active Crohns Disease",{"date":412,"type":45},{"date":506,"type":45},"2025-03-17",{"date":508,"type":21},"2033-12-31",{"name":510,"class":52},"Hoffmann-La Roche",372,{"id":513,"slug":4,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":519,"minAge":17,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":539},"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":521,"type":21},582,[24],"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.",[525],"Ovarian Cancer",[527,528,529,530,531],"Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab",{"date":412,"type":45},{"date":534,"type":45},"2025-03-19",{"date":536,"type":21},"2032-01-31",{"name":538,"class":52},"Daiichi Sankyo",208,{"id":541,"slug":4,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":16,"minAge":497,"maxAge":18,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"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":548,"type":21},350,[24],"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).",[552],"Moderately to Severely Active Ulcerative Colitis",{"date":412,"type":45},{"date":555,"type":45},"2024-12-11",{"date":557,"type":21},"2031-01-30",{"name":510,"class":52},200,{"id":561,"slug":4,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":11,"sex":16,"minAge":566,"maxAge":112,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":581},"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":568,"type":21},2000,[24],"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.",[572],"Chronic Obstructive Pulmonary Disease",[574],"chronic obstructive pulmonary disease, COPD",{"date":412,"type":45},{"date":577,"type":45},"2023-06-28",{"date":579,"type":21},"2034-07-01",{"name":510,"class":52},486,{"id":583,"slug":4,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":596,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":612},"100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply","100 Years",{"count":591,"type":21},1400,[24],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[595],"Early Breast Cancer",[597,598,599,600,601,602,603,604,605],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":412,"type":45},{"date":608,"type":45},"2024-02-28",{"date":610,"type":21},"2030-09-20",{"name":264,"class":52},223,{"id":614,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":160,"conditions":617,"keywords":618,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":622,"locationsCount":180},"100479138",{"count":158,"type":21},[24],[162],[164,165,166,167,168,169,170,171,172],{"date":412,"type":45},{"date":175,"type":45},{"date":177,"type":21},{"name":179,"class":52},{"id":624,"slug":4,"hasResults":11,"nctId":625,"briefTitle":626,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":11,"sex":16,"minAge":628,"maxAge":629,"enrollmentInfo":630,"targetDuration":4,"studyType":632,"phases":4,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":647},"100268233","NCT02771236","Clinical and Molecular Studies in Families With Inherited Eye Disease","* INCLUSION CRITERIA:\n\nTo be eligible, the following inclusion criteria must be met, where applicable;\n\n1. Participant must be four years of age or older.\n2. Participant must understand and sign the protocol s informed consent document.\n3. Individuals or family members of individuals with inherited eye diseases, either congenital, childhood, or age related.\n4. All participants must be able to cooperate with study examination and phlebotomy.\n\nEXCLUSION CRITERIA:\n\nA participant is not eligible if any of the following exclusion criteria are present:\n\n1. Participant has a disease, infection, or trauma that mimics inherited cataracts, retinal degenerations, glaucoma, etc.\n2. Participant has a significant active infection (an infection requiring treatment as determined by the investigator) or a history of chronic or recurrent infections.\n3. Participant requires sedation for study purposes.","4 Years","120 Years",{"count":631,"type":21},5000,"OBSERVATIONAL","Background:\n\nGenes are the basic units of heredity. When genes are changed, certain cells don t work like they should. Researchers want to try to better understand the genetic conditions that are linked with inherited eye diseases.\n\nObjective:\n\nTo try to identify the genes linked to the development of inherited eye diseases.\n\nEligibility:\n\nPeople ages 4 and older who have or have a family member with an inherited eye disease\n\nDesign:\n\nParticipants will be screened with medical history and medical records.\n\nParticipants will have one visit that will take 3-4 hours. This will include:\n\nMedical and family history\n\nEye exam: This includes the pupil being dilated.\n\nElectroretinography: A small electrode is taped to the forehead. Participants sit in the\n\ndark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put in\n\nthe eyes. They will watch flashing lights.\n\nBlood tests\n\nSaliva sample: They will spit into a container or have the inside of their cheek swabbed.\n\nGenetic testing will be done on participants blood or saliva.\n\nParticipants may meet with the researchers to discuss their genetic tests.\n\n...",[635],"Inherited Eye Disease",[637,638],"Genetics","Natural History",{"date":412,"type":45},{"date":641,"type":45},"2016-10-04",{"date":643,"type":21},"2032-01-01",{"name":645,"class":646},"National Eye Institute (NEI)","NIH",10,""]