[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Georgia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":650},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,145,0,25,[9,53,86,119,148,168,197,220,245,268,290,313,334,355,378,401,429,458,480,501,522,550,572,594,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100626090","phase-1-a-study-of-air-001-in-adults-with-alpha-1-antitrypsin-deficiency-aatd-100626090",false,"NCT07431112","A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)","Phase 1, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered AIR-001 in Adults With AATD Due to PiZZ Genotype","RepAIR1","Inclusion Criteria:\n\n1. Male or female participants \\>18 years and \\\u003C75 years of age at the time of signing informed consent\n2. Total serum AAT levels \\\u003C 11µM (57 mg\u002FdL)\n3. Pi\\*ZZ genotype confirmed by DNA sequencing within the SERPINA1 gene with no known co-occurring SERPINA1 null variants\n4. Spirometry: Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted\n5. Non-smoker, including vaping, for at least 6 months prior to screening\n6. Body mass index between 18-33.0 kg\u002Fm²\n7. Body weight ≥ 45 kg and ≤110 kg\n8. Willing and able to give written informed consent prior to the initiation of any study procedure by the participant\n9. Negative beta human chorionic gonadotropin (β-hCG) at enrolment for women of childbearing potential (WOCBP) only.\n10. Participants who are either a WOCBP or male participant who is heterosexually active with a WOCBP must consent to use a highly effective method of contraception from screening visit until at least 4 weeks after the last dose of investigational medicinal product (IMP).\n11. Willing and able to comply with the study design schedule, all study procedures, and other requirements\n\nExclusion Criteria:\n\n1. Female participants who are nursing or lactating\n2. Participant has received AAT augmentation therapy within 30 days prior to Screening Visit or plans to receive AAT augmentation therapy at any time during study participation.\n3. Known or suspected allergy or intolerance to AIR-001 or its components\n4. Acute respiratory tract infection or clinically-diagnosed chronic obstructive pulmonary disease (COPD) exacerbation that required antibiotic treatment and\u002For systemic corticosteroids within the 8 weeks prior to dosing.\n5. Positive screening test for COVID-19 and\u002For Influenza.\n6. Lung disease that requires use of continuous oral corticosteroids, continuous supplemental oxygen, day-time ventilatory support, or any participant who is on a lung transplant waiting list.\n7. Liver Fibrosis score \\> 10 kPa defined by screening liver elastography, historical liver biopsy showing ≥ F3 fibrosis (METAVIR or comparable scoring system), or established diagnosis of hepatic cirrhosis.\n8. Any of the following screening laboratory abnormalities:\n\n   1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) \\> 3 x upper limit of normal (ULN)\n   2. Total bilirubin \\> ULN (note: for participants with documented Gilbert's syndrome and direct bilirubin ≤ ULN , exclusion criterion is total bilirubin is \\> 2.5 mg\u002FdL)\n   3. INR \\> ULN (for participants taking stable doses of anticoagulants, the exclusion criterion is INR \\> 3.0)\n   4. Platelet count ≤ 150 k\u002FμL\n   5. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73m² by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation\n   6. Urine Albumin-to-Creatinine Ratio \\> 300 mg\u002Fg\n   7. Urine Protein-to-Creatinine Ratio \\> 500 mg\u002Fg\n9. Prolonged QT interval on electrocardiogram (ECG), defined as QTcF ≥ 450ms (men) or ≥ 470ms (women)\n10. ECG findings at screening that render measurements of QT interval imprecise.\n11. History of congestive heart failure, serious cardiac arrythmias requiring anti-arrhythmic medications or unexplained black-outs or fainting episodes with a suspected cardiac origin\n12. Positive screening test or known chronic infection with Hepatitis B, Hepatitis C, or HIV.\n13. Known history of coagulopathy or bleeding diathesis\n14. History or intolerance to subcutaneous (SC) injection including relevant dermatological conditions affecting standard injection sites\n15. History or presence of any medical condition, behavioral or psychiatric disorder, or planned surgical procedure or surgical history that may interfere with participation in the study or interpretation of study results, and\u002For put the participant at significant risk (in the opinion of the investigator) if he\u002Fshe participates in the study.\n16. History of any lung-volume reduction procedure in the 6 months prior to screening.\n17. Laboratory value(s) outside the laboratory reference range that is (are) considered to be clinically significant and may affect the safety, efficacy, PK, or PD assessments or interpretation by the Investigator, at screening\n18. History of alcohol or drug abuse within the past three months\n19. Current or previous participation in any other clinical study where the participant has received a dose of an IMP within 3 months or 5 half-lives of the IMP, whichever is longest, prior to Screening Visit\n20. Any previous gene replacement or DNA-editing therapy\n21. Any previous use of an RNA-based therapeutic (except for AIR-001 or RNA-based vaccines) within the 6 months prior to the Screening Visit or at any time if stopped due to drug-related adverse event.\n22. Use of any new prescription, vaccine, herbal remedy, over-the-counter medication, or supplement, or changes in chronic therapies within the 28 days prior to dosing unless approved by study Medical Monitor.","ALL","18 Years","74 Years",{"count":22,"type":23},54,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.",[29],"Alpha 1 Antitrypsin Deficiency",[31,32,33,34,35,36,37,38,39,29],"Lung Diseases","Liver Diseases","Respiratory Tract Diseases","Genetic Disease","Inborn Congenital, Hereditary, Neonatal Diseases and Abnormalities","Subcutaneous Emphysema","Emphysema","Pathologic Processes","Pathological Conditions, Signs and Symptoms","RECRUITING","2026-08-24",{"date":43,"type":44},"2026-08-25","ACTUAL",{"date":46,"type":44},"2026-03-17",{"date":48,"type":23},"2029-01",{"name":50,"class":51},"AIRNA Corporation","INDUSTRY",8,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100623056","phase-1-a-phase-i-dose-escalation-and-dose-expansion-study-to-investigate-the-pharmacokinetics-and-safety-of-subcutaneous-durvalumab-100623056","NCT07391670","A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab","A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours","IMFINZI-subQ","Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of ≥ 12 weeks at enrolment.\n* Adequate organ and marrow function.\n* Minimum body weight \\> 30 kg.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).\n* Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.\n* Have not progressed following definitive concurrent chemoradiation.\n\nLS-SCLC Participants -\n\n* Histologically or cytologically documented LS-SCLC (Stage I-III).\n* Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment.\n* Have not progressed following definitive concurrent chemoradiation.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Unresectable HCC based on histopathological confirmation.\n* No prior systemic therapy for unresectable HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC.\n* Child-Pugh Score class A.\n* Measurable disease as defined by RECIST v1.1.\n\nExclusion Criteria:\n\n* Active or prior documented autoimmune disease requiring systemic treatment.\n* Uncontrolled infection (including human immunodeficiency virus \\[HIV\\], hepatitis B or C).\n* Prior exposure to immune checkpoint inhibitors.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Active pneumonitis or interstitial lung disease requiring systemic therapy.\n\nLS SCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Extensive-stage disease.\n* History of Grade ≥ 2 pneumonitis.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Hepatic encephalopathy.\n* Uncontrolled ascites.\n* Active gastrointestinal (GI) bleeding.",{"count":62,"type":23},40,[26],"The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).",[66],"Solid Tumours",[68,69,70,71,72,73,74,75,76,77],"Pharmacokinetics","Non-small cell lung cancer (Stage III, unresectable)","Small cell lung cancer (Limited stage)","Hepatocellular carcinoma (Unresectable)","Subcutaneous","Human hyaluronidase","Monoclonal antibody","Programmed cell death ligand 1 (PD-L1)","Programmed cell death protein 1","Anticancer therapy",{"date":43,"type":44},{"date":80,"type":44},"2026-03-31",{"date":82,"type":23},"2027-08-30",{"name":84,"class":51},"AstraZeneca",19,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":18,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":24,"phases":97,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100622055","phase-2-study-to-evaluate-the-pharmacodynamics-safety-and-efficacy-of-sky-0515-in-participants-with-huntingtons-disease-100622055","NCT07378644","Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","A Phase 2\u002F3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","FALCON-HD","Inclusion Criteria:\n\n* 25 years or older.\n* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).\n* Total Functional Capacity (TFC) score of 10 or more).\n* Total Motor Score (TMS) of 6 or more).\n* Independence Score (IS) of 70 or more).\n* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.\n* Men must agree to use birth control during the study and for 90 days after the last dose.\n* Agree to sign a consent form and follow the study's rules and schedule.\n\nExclusion Criteria:\n\n* Other Serious health problems or brain\u002Fspinal issues that could interfere with the study or make procedures unsafe.\n* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.\n* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.\n* Severe allergies or have reacted badly to similar drugs in the past.\n* Taking medications or treatments that might interfere with the study.\n* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).\n* Any kind of gene therapy.\n* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.\n* Liver function tests show significant abnormalities.\n* Positive for hepatitis B, hepatitis C, or HIV.\n* Pregnancy, breastfeeding, or planning to become pregnant during the study.","25 Years",{"count":96,"type":23},400,[98,99],"PHASE2","PHASE3","The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.",[102],"Huntington Disease",[104,105,106,107,102,108,109,110],"SKY-0515","Skyhawk","HTT","Neurodegenerative","mRNA","Splicing","Mutant Huntingtin protein",{"date":43,"type":44},{"date":113,"type":44},"2026-01-06",{"date":115,"type":23},"2029-08",{"name":117,"class":51},"Skyhawk Therapeutics, Inc.",22,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":24,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352","NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":128,"type":23},210,[98],"This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[132],"Graves' Disease",[134,135,136,137,138,139],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":43,"type":44},{"date":142,"type":44},"2025-06-19",{"date":144,"type":23},"2027-05",{"name":146,"class":51},"Immunovant Sciences GmbH",163,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":126,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100572003","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100572003","NCT06727604",{"count":153,"type":23},240,[98],"This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.\n\nThe primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \\[T3\\] or free triiodothyronine \\[FT3\\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.",[132],[134,158,159,160,139],"Anti Thyroid Drug","Hyperthyroidism","Autoimmune thyroid disease",{"date":43,"type":44},{"date":163,"type":44},"2024-12-17",{"date":165,"type":23},"2028-06",{"name":146,"class":51},134,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":24,"phases":177,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":176,"type":23},626,[98,99],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[180,181],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[183,184,185,181,186,187,188],"KRAS G12C","Non-small cell lung cancer","NSCLC","Adagrasib","Krazati","TPS",{"date":43,"type":44},{"date":191,"type":44},"2020-12-02",{"date":193,"type":23},"2029-10-31",{"name":195,"class":51},"Mirati Therapeutics Inc.",770,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":24,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100598128","phase-3-a-study-of-orelabrutinib-in-patients-with-primary-progressive-multiple-sclerosis-100598128","NCT07067463","A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","60 Years",{"count":206,"type":23},705,[99],"Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[210],"Multiple Sclerosis (MS) Primary Progressive","2026-08-21",{"date":41,"type":44},{"date":214,"type":44},"2026-03-23",{"date":216,"type":23},"2030-07",{"name":218,"class":51},"Zenas BioPharma (USA), LLC",48,{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":126,"enrollmentInfo":228,"targetDuration":4,"studyType":24,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":229,"type":23},645,[98],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[233,234,235,236],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":43,"type":44},{"date":239,"type":44},"2025-05-27",{"date":241,"type":23},"2028-03",{"name":243,"class":51},"Spyre Therapeutics, Inc.",267,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":24,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100640696","phase-3-a-study-to-assess-efficacy-and-safety-of-efgartigimod-ph20-sc-pfs-in-adult-participants-with-graves-disease-100640696","NCT07596849","A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.","A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs","VitaliThy","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.\n* Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \\>=ULN (upper limit of normal) at screening\n* Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) \\\u003C0.1 mIU\u002FL at screening\n* Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening\n\nExclusion Criteria:\n\n* History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter)\n* History of RAI (radioactive iodine) therapy or received a total thyroidectomy\n* T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received \\\u003C6 weeks before screening\n* Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.\n* Graves' orbitopathy\u002FThyroid Eye Disease (GO\u002FTED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and\u002For planned corrective surgery\u002Firradiation or medical therapy during the study",{"count":254,"type":23},230,[99],"The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.\n\nThe study consists of a part A double-blinded treatment period, a part B treatment\u002Fobservation period and a part C open-label treatment\u002Fobservation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment.\n\nThe total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fvitalithy",[258],"Graves Disease","2026-08-20",{"date":211,"type":44},{"date":262,"type":44},"2026-06-10",{"date":264,"type":23},"2030-05",{"name":266,"class":51},"argenx",12,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100631683","phase-2-a-study-to-evaluate-pharmacokinetics-pk-and-safety-of-subcutaneous-sc-ublituximab-administered-at-various-injection-sites-and-relative-bioavailability-via-autoinjector-ai-versus-syringe-subcutaneously-in-participants-with-multiple-sclerosis-ms-100631683","NCT07503873","A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)","A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).\n2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.\n3. Neurologically stable for more than (\\>) 30 days prior to screening and Day 1.\n4. Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.\n\nExclusion Criteria:\n\n1. Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).\n2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome.\n3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.\n4. Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.\n5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.\n6. Females who are pregnant or nursing.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.","65 Years",{"count":277,"type":23},350,[98],"The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.",[281],"Multiple Sclerosis",{"date":211,"type":44},{"date":284,"type":44},"2026-04-01",{"date":286,"type":23},"2029-05-30",{"name":288,"class":51},"TG Therapeutics, Inc.",39,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":24,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100599987","phase-3-a-study-to-assess-the-efficacy-and-safety-of-empasiprubart-in-adults-with-cidp-100599987","NCT07091630","A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emnergize","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has residual disability and active disease\n* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)\n* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP\n\nExclusion Criteria:\n\n* Meets the criteria for possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Sensory CIDP (including sensory-predominant CIDP)\n* Polyneuropathy of other causes\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation",{"count":299,"type":23},160,[99],"The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femnergize",[303,304,305],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy",{"date":211,"type":44},{"date":308,"type":44},"2025-09-16",{"date":310,"type":23},"2031-01-23",{"name":266,"class":51},78,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":24,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100564690","liverage---cirrhosis-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-cirrhosis-100564690","NCT06632457","LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Cirrhosis","A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction Associated Steatohepatitis (NASH\u002FMASH) Cirrhosis","Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg\u002Fm2(≥25 kg\u002Fm2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB\u002Fm, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\\u003C5% or FibroScan® with CAP \\\u003C288 dB\u002Fm is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis\u002Fsteatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\\u003C5 years) of significant alcohol consumption, defined as an average of \\>140 g\u002Fweek in female patients and \\>210 g\u002Fweek in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\\u003C3.5 g\u002FdL (\\\u003C35.0 g\u002FL)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\\u003C20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\\u003C100,000\u002FµL (\\\u003C100 GI\u002FL)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological\u002Fsurgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply",{"count":321,"type":23},1590,[99],"This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg\u002Fm2 or more or\n* 25 kg\u002Fm2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.",[325],"Metabolic Dysfunction Associated Steatohepatitis",{"date":211,"type":44},{"date":328,"type":44},"2024-11-12",{"date":330,"type":23},"2029-06-05",{"name":332,"class":51},"Boehringer Ingelheim",445,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":24,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},"100564689","liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689","NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply",{"count":342,"type":23},1800,[99],"This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[346,347],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":211,"type":44},{"date":350,"type":44},"2024-10-14",{"date":352,"type":23},"2031-12-27",{"name":332,"class":51},528,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":24,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100552341","phase-2-a-trial-of-lu-ag13909-in-adult-participants-with-cushings-disease-100552341","NCT06471829","A Trial of Lu AG13909 in Adult Participants With Cushing's Disease","A Phase II, Multi-site, Open-label, Dose-titration Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AG13909 in Adults With Cushing's Disease","BalanCeD","Inclusion Criteria:\n\n* The participant is a man or woman with a confirmed diagnosis of adrenocorticotropic hormone (ACTH) driven CD of pituitary source as per current guidelines\n* Morning plasma ACTH levels \\> lower limit of normal (LLN) and\n* Evidence of a pituitary origin of the excess ACTH:\n\n  i. Either MRI confirmation of pituitary adenoma \\>6 millimeters (mm), or ii. inferior petrosal sinus gradient \\>2, or iii. histopathology confirmation of ACTH-secreting tumour\n* The participant has a 24-hour UFC \\>1.5 × ULN (the mean of ≥3 days of 24-hour urine collection).\n* Apart from CD and associated well-controlled comorbidities (for example, diabetes mellitus and hypertension), the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the safety laboratory tests.\n* For participants on medical treatment for hypercortisolism due to CD, pre-defined washout periods must be completed prior to the Baseline efficacy assessments.\n\nExclusion Criteria:\n\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not willing to use adequate contraceptive methods.\n* The participant has a clinically significant abnormal laboratory value, ECG parameter, vital signs value, or other safety findings at the Screening Visit that indicate a potential risk to the participant's safety if enrolled, in the opinion of the investigator.\n* The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.\n* The participant has immediate need for pituitary surgery within 6 months from screening in the opinion of the investigator.\n* The participant has severe CD per investigator judgement; among others, this could be participants with:\n\n  i. poorly controlled hypertension ii. poorly controlled diabetes mellitus iii. severe psychiatric illness iv. compression of the optic chiasm causing any visual field defect or risk thereof v. very high risk of thromboembolic events\n* The participant had pituitary surgery \\\u003C3 month prior to screening.\n* The participant had pituitary radiotherapy within the last 10 years.\n\nOther protocol-defined criteria apply.","70 Years",{"count":365,"type":23},18,[98],"This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol. The main goals of this trial are to learn about\n\n1. the effect of Lu AG13909 on cortisol levels.\n2. the safety and tolerability of Lu AG13909.\n3. the pharmacokinetic parameters of Lu AG13909 (how the drug is absorbed, distributed, and processed by the body).",[369],"Cushing's Disease",{"date":211,"type":44},{"date":372,"type":44},"2024-06-19",{"date":374,"type":23},"2027-10-31",{"name":376,"class":51},"H. Lundbeck A\u002FS",28,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":385,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":400},"100549191","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100549191","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).","16 Years","80 Years",{"count":388,"type":23},1200,[99],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[392],"Crohn's Disease",{"date":211,"type":44},{"date":395,"type":44},"2024-06-05",{"date":397,"type":23},"2029-11-12",{"name":399,"class":51},"Merck Sharp & Dohme LLC",499,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":412,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":428},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","85 Years",{"count":411,"type":23},385,[98],"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[234,392],[416,417,418,419,420,407],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":211,"type":44},{"date":423,"type":44},"2024-07-18",{"date":425,"type":23},"2030-06",{"name":427,"class":51},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":24,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":457},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":229,"type":23},[26,98],"Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[441,442,443,444,445,446,447,448,449],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":211,"type":44},{"date":452,"type":44},"2021-09-13",{"date":454,"type":23},"2029-11",{"name":456,"class":51},"BeOne Medicines",115,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":24,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"100631162","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-systemic-sclerosis-100631162","NCT07497087","A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)","VERANDA™-SSc","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) criteria for SSc.\n3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).\n4. Disease onset (defined by first non-RP \\[Raynaud's phenomenon\\] symptom) must be within 7 years of Visit 1.\n5. Trial participants with dcSSc must have evidence of active disease during screening.\n6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.\n7. FVC % predicted ≥45% at Visit 1.\n8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.\n9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.\n10. Patients may be either untreated or on stable treatment with permitted immunosuppressive\u002Fimmunomodulatory agents and\u002For nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period\n\nExclusion criteria:\n\n1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.\n2. Any suicidal behaviour in the past 2 years.\n3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.",{"count":467,"type":23},448,[99],"Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day.\n\nParticipants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[471],"Systemic Sclerosis","2026-08-19",{"date":259,"type":44},{"date":475,"type":44},"2026-07-27",{"date":477,"type":23},"2030-03-17",{"name":332,"class":51},246,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":487,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":24,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":500},"100609861","phase-3-a-study-to-find-out-if-bi-764198-helps-adults-and-adolescents-with-a-kidney-condition-called-focal-segmental-glomerulosclerosis-fsgs-100609861","NCT07220083","A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)","A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants","Inclusion criteria:\n\n1. Male or female participants ≥12 years old on the day of signing informed consent\u002Fassent (Visit 1)\n2. Weight of ≥40 kg at the screening visit (Visit 1)\n3. Body mass index (BMI) of ≤40 kg\u002Fm² at the screening visit (Visit 1)\n4. Participants with a diagnosis prior to the screening visit (Visit 1) of either:\n\n   * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR\n   * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)\n5. Urine protein-creatinine ratio (UPCR) ≥1500 mg\u002Fg based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)\n6. Estimated glomerular filtration rate (eGFR)\n\n   * For adult participants (≥18 years): ≥25 mL\u002Fmin\u002F1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)\n   * For adolescent participants (12 to \\\u003C18 years): ≥25 mL\u002Fmin\u002F1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)\n2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)\n3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)\n4. A history of organ transplantation or planned organ transplantation during the course of the trial\n5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.","12 Years",{"count":489,"type":23},286,[99],"PODOMOUNT-pFSGS\n\nThis study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS.\n\nParticipants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. 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.\n\nParticipants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS.\n\nParticipants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. 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.",[493],"Focal Segmental Glomerulosclerosis",{"date":259,"type":44},{"date":496,"type":44},"2026-02-16",{"date":498,"type":23},"2029-01-24",{"name":332,"class":51},306,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":385,"maxAge":386,"enrollmentInfo":509,"targetDuration":4,"studyType":24,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100607164","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607164","NCT07184996","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","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 Ulcerative Colitis.","SUNSCAPE-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 UC 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\n\nExclusion Criteria:\n\n* Participants with Crohn's Disease (CD), indeterminate colitis\n* Current diagnosis of Ulcerative Proctitis\n* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \\>3 bowel resections\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapies prior to baseline\n* Participants with prohibited medications or therapies prior to baseline\n* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":510,"type":23},980,[99],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* 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* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)\n\nThe treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.",[233],{"date":259,"type":44},{"date":516,"type":44},"2025-10-08",{"date":518,"type":23},"2028-05-09",{"name":520,"class":51},"Sanofi",219,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":530,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":24,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":7},"100566774","phase-2-a-phase-2-efficacy-and-safety-study-of-gal-101-2-ophthalmic-solution-in-non-foveal-geographic-atrophy-secondary-to-non-neovascular-amd-100566774","NCT06659549","A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD","A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study","eDREAM","Inclusion Criteria:\n\n* ≥55 years of age\n* Willing and able to provide written informed consent\n* Willing and able to comply with the study schedule and study assessments\n* Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution\n* BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20\u002F100 Snellen equivalent). Criterion will be confirmed at Baseline\n* Refractive error between +3 and -6 diopters spherical equivalent in the study eye\n* Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline\n* Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center\n\n  1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2\n  2. If GA is multifocal, at least 1 lesion ≥1.25 mm2\n  3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \\[RPE\\] and outer retina)\n  4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea\n  5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \\>300 µm from image edges\n  6. GA lesions must be \\>300 µm from the optic disc and\u002For peripapillary atrophy\n  7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2\n\nExclusion Criteria:\n\n1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline\n2. History of laser therapy in the macular region, regardless of indication\n3. History of herpes zoster\n4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period\n5. GA with cumulative area \\\u003C1.25 mm2\n6. Any GA lesion within 100 µm radius from the center point of the fovea\n7. Axial length \\>26 mm\n8. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)\n9. Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period\n10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period\n11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period\n12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period\n\n    Non-study Eye:\n13. BCVA of \\\u003C5 letters using ETDRS chart (i.e., 20\u002F800 Snellen equivalent)\n\n    Either Eye:\n14. History of uveitis\n15. GA secondary to any condition other than non-neovascular AMD\n16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline\n17. Underwent investigational treatment for AMD within 6 months before Visit 1a\n\n    General Exclusion Criteria:\n18. History of therapeutic radiation to the cranium\n19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients\n20. History of malignant disease\n21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period\n22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period\n23. Use of lutein \\>10 mg per day or zeaxanthin \\>2 mg per day within 1 month before Visit 1a, or planned use during the study period\n24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data\n25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation\n26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline\n27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP","55 Years",{"count":532,"type":23},110,[98],"Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.",[536],"Geographic Atrophy of the Macula",[538,539,540,541,542],"AMD","Geographic Atrophy","Age Related Macular Degeneration","Amyloid-Beta","Eye-drops",{"date":259,"type":44},{"date":545,"type":44},"2025-01-10",{"date":547,"type":23},"2027-05-30",{"name":549,"class":51},"Galimedix Therapeutics Inc",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":24,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":62},"100547974","phase-2-safety-and-efficacy-of-3-dose-levels-of-nmd670-in-adult-patients-with-myasthenia-gravis-100547974","NCT06414954","Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR\u002FMuSK-Ab+ Myasthenia Gravis","SYNAPSE-MG","Inclusion Criteria:\n\n* Participant must be a male or female being 18 or more, at the time of signing the informed consent\n* Diagnosis of MG, MGFA class II, III or IV\n* Documented positive AChR or MuSK antibody test.\n* Participant must be able to swallow tablets\n* Body mass index between 18 and 35 kg\u002Fm2, inclusive, at screening, and with a minimum weight of 40 kg\n* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Participant is capable of and has given signed informed consent\n\nExclusion Criteria:\n\n* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study\n* Participants with other significant clinical and\u002For laboratory safety findings that may interfere with the conduction or interpretation of the study\n* Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1\n* Participants with history of poor compliance with relevant MG therapy\n* Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding",{"count":559,"type":23},84,[98],"This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.",[563,564],"Myasthenia Gravis","Myasthenia Gravis, MuSK",{"date":211,"type":44},{"date":567,"type":44},"2024-05-16",{"date":569,"type":23},"2026-12",{"name":571,"class":51},"NMD Pharma A\u002FS",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":24,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":593},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.",{"count":581,"type":23},1700,[99],"This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[585,586],"Idiopathic Pulmonary Fibrosis","Progressive Pulmonary Fibrosis",{"date":259,"type":44},{"date":589,"type":44},"2024-05-06",{"date":591,"type":23},"2027-05-05",{"name":332,"class":51},373,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":611,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":627},"100444268","phase-2-treatment-of-acute-ischemic-stroke-remedy2-trial-100444268","NCT05065216","Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)","Phase 2\u002F3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)","ReMEDy2","Inclusion Criteria:\n\n1. Participant is between 18 and 90 years of age inclusive.\n2. Participant weight is 40 kg to 166 kg inclusive.\n3. Participant to be randomized and treatment initiated within 24 hours of last known normal\u002FAIS stroke onset.\n4. Participant has NIHSS ≥5 and ≤15 at approximately the time of randomization. This criterion also applies to participants who meet the following conditions:\n\n   * The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke \u002F stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and\n   * Participant meets all other inclusion and exclusion criteria, including repeat brain imaging to rule out hemorrhagic transformation.\n5. Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative.\n6. If participant has received fibrinolytic treatment for AIS within 4.5 hours of last know normal\u002FAIS stoke onset and at least 6 hours after completing fibrinolytic treatment, and the participant meets all of the following criteria:\n\n   * Participant's initial NIHSS score prior to fibrinolytics was ≤15; and\n   * At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and\n   * The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and\n   * Participant meets all other inclusion and exclusion criteria including repeat brain imaging to rule out hemorrhagic transformation.\n7. Participant and\u002For legally authorized representative is able to provide informed consent.\n8. Participant is willing and able to comply with the study protocol, in the Investigator's judgment.\n\nExclusion Criteria:\n\n1. At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke.\n2. Participant has image findings with symptomatic large vessel occlusion at one or more of the following locations: Intracranial carotid I\u002FT\u002FL or M1 segment MCA, vertebral or basilar artery (BA).\n3. Participant has large core of established infarction defined as ASPECTS 0-5.\n4. Participant has or will receive MT for their current AIS.\n5. Participant has suspected or confirmed extracranial arterial dissection.\n6. Participant has imaging findings and\u002For symptoms consistent with a brain stem or cerebellar stroke. Posterior cerebral artery strokes without any associated brain stem or cerebellar involvement are allowable.\n7. Participant has any recorded SBP \\\u003C100 mmHg or MAP \\\u003C65 mmHg; MAP = DBP + \\[1\u002F3 (SBP - DBP)\\] (measured with noninvasive BP cuff type monitor) after stroke symptom onset and prior to randomization.\n8. Participant is currently prescribed angiotensin-converting enzyme inhibitor (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment through Day 29 ±1 day (8 days after last treatment).\n9. Participant is currently prescribed an ACEi, and the last dose of the ACE inhibitor medication is reported to have been taken \\\u003C 24 hours before start of IV study drug infusion as stated by participant or participant's representative.\n10. Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization.\n11. Participant has a diagnosis or suspected diagnosis of hereditary angioedema (HAE) or is taking or prescribed medications commonly used as prophylaxis\u002Ftreatment of HAE, such as C1-esterase inhibitors (Cinryze, Berinert, Ruconest, Haegarda), Danazol, kallikrein inhibitors (Ecallantide, Berotralstat, Lanadelumab), Bradykinin B2 Receptor Antagonists (Icatibant), or other medication designed to influence the kallikrein-kinin system.\n12. Life expectancy estimated at ≤1 year prior to enrollment.\n13. Participant has clinical evidence of an active infection at the time of enrollment requiring parenteral treatment or hospitalization to monitor or manage the infection.\n\n    NOTE: Treatment of uncomplicated infections with oral antibiotics would not be an exclusion (for example, the treatment of uncomplicated urinary tract infections or sinus infections with oral antibiotics would not be exclusionary).\n14. Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).\n15. Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator.\n16. Participants of child-bearing potential must agree to use medically acceptable contraceptive measures to prevent pregnancy. All participants of childbearing potential (defined as sexually mature participants who have had menses within the preceding 24 months and have not undergone permanent sterilization methods such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) must have a negative serum pregnancy test performed locally at screening. Participants of childbearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization. If participating in sexual activity that could lead to pregnancy, participants must use 2 reliable methods (1 per partner is acceptable) of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period.\n\n    Participants participating in sexual activity must agree to use, or for their partner to use highly effective birth control methods (those with a failure rate of less than 1% per year when used consistently and correctly) until they have completed the study (after the Day 90 visit). Such methods include:\n    * Combined (estrogen and progesterone containing) hormonal oral, intravaginal, or transdermal contraception associated with the inhibition of ovulation\n    * Progesterone-only oral, injectable, or implantable hormonal contraception associated with the inhibition of ovulation\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Sexual abstinence Participants who are not of reproductive potential (who have been postmenopausal for more than 24 consecutive months or have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) are not required to use contraception.\n\n    Participants are prohibited from sperm donation. NOTE: A negative serum pregnancy test will be documented during screening if a participant is of child-bearing potential.\n17. Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening.\n18. Participant does not have sufficient venous access for infusion of study treatment or blood sampling.\n19. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.\n20. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.","90 Years",{"count":604,"type":23},728,[98,99],"This is a Phase 2\u002F3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.",[608,609,610],"Acute Stroke","Ischemic Stroke","Stroke",[612,613,614,615,616,617,618,619,620],"acute","ischemic","stroke","AIS","tPA","LVO","MT","KLK1","Kallikreins",{"date":211,"type":44},{"date":623,"type":44},"2021-11-07",{"date":569,"type":23},{"name":626,"class":51},"DiaMedica Therapeutics Inc",86,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":24,"phases":637,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":649},"100629272","phase-3-dareon---lung-1-a-study-in-people-with-advanced-small-cell-lung-cancer-to-compare-obrixtamig-plus-atezolizumab-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100629272","NCT07472517","DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy","DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria :\n\n1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)\n2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.\n3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.\n4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:\n\n   * Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation\n   * Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy\n7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n3. Radiotherapy of any anatomical site within 7 days prior to randomisation\n4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and\u002For CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described\n5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma\u002Fatopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and\u002For controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.\n\nFurther exclusion criteria apply.",{"count":636,"type":23},670,[99],"This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.\n\nParticipants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.\n\nParticipants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[640,641],"Small Cell Lung Cancer (SCLC)","Extensive-stage Small Cell Lung Cancer (ES-SCLC)","2026-08-18",{"date":472,"type":44},{"date":645,"type":44},"2026-04-13",{"date":647,"type":23},"2029-07-30",{"name":332,"class":51},245,""]