[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Bulgaria\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":644},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,299,0,25,[9,52,81,106,134,161,187,215,237,260,284,307,334,356,375,402,425,460,485,509,531,561,583,602,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842",false,"NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":21,"type":22},590,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[29],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[31,32,33,34,35,36,37,38],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat","RECRUITING","2026-08-24",{"date":42,"type":43},"2026-08-25","ACTUAL",{"date":45,"type":43},"2026-01-02",{"date":47,"type":22},"2031-08-12",{"name":49,"class":50},"Bristol-Myers Squibb","INDUSTRY",320,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"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":61,"type":22},210,[25],"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.",[65],"Graves' Disease",[67,68,69,70,71,72],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":42,"type":43},{"date":75,"type":43},"2025-06-19",{"date":77,"type":22},"2027-05",{"name":79,"class":50},"Immunovant Sciences GmbH",163,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":90,"type":22},450,[26],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[94],"Bipolar Disorder Type I With Mania",[96,97,98],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":42,"type":43},{"date":101,"type":43},"2025-07-18",{"date":103,"type":22},"2028-06-13",{"name":49,"class":50},174,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"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":114,"type":22},626,[25,26],"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.",[118,119],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[121,122,33,119,123,124,125],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":42,"type":43},{"date":128,"type":43},"2020-12-02",{"date":130,"type":22},"2029-10-31",{"name":132,"class":50},"Mirati Therapeutics Inc.",770,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100653263","phase-3-a-study-to-evaluate-effect-of-azd6234-in-adult-participants-with-obesity-or-overweight-with-weight-related-comorbidity-without-type-2-diabetes-mellitus-100653263","NCT07784725","A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus","A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)","SELENE 1","Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥30 kg\u002Fm2 OR BMI ≥27 kg\u002Fm2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol\u002Fmol), and\u002For treatment with glucose-lowering agent(s) within 3 months prior to Screening\n* Significant hepatobiliary disease and\u002For any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.",{"count":143,"type":22},2500,[26],"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment",[147],"Obesity or Overweight",[149,150,151],"Obesity","Overweight","AZD6234","2026-08-21",{"date":42,"type":43},{"date":155,"type":43},"2026-08-19",{"date":157,"type":22},"2029-05-21",{"name":159,"class":50},"AstraZeneca",212,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100650113","phase-3-a-study-of-secutrelvir-in-participants-with-coronavirus-disease-2019-covid-19-who-are-at-high-risk-for-progression-to-severe-disease-100650113","NCT07743580","A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease","A Phase 3 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19 Who Are at High Risk for Progression to Severe Disease","Key Inclusion Criteria:\n\n* Must be 12 to \\\u003C18 years of age (where permitted by local regulations) with a body weight ≥40 kilograms, or ≥18 years of age regardless of body weight, at the time of signing the informed consent form.\n* Presence of risk factors for progression to severe COVID-19 at the time of screening.\n* Must have ≥1 COVID-19 signs\u002Fsymptoms that are at least mild in severity, and the symptoms must still be present in the 24 hours prior to randomization.\n* Confirmed SARS-CoV-2 infection, as determined by any SARS-CoV-2 test (for example, quantitative reverse transcription polymerase chain reaction, antigen test) approved according to local regulations, of any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva), collected ≤72 hours prior to randomization.\n* Must be randomized within 72 hours of symptom onset, defined as the time when the first COVID-19 symptom occurs.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receiving the investigational intervention.\n* Unable or unwilling to take other locally available COVID-19 antivirals (for example, nirmatrelvir\u002Fritonavir, molnupiravir, remdesivir, ensitrelvir).\n\nKey Exclusion Criteria:\n\n* Planned \\>24 hours hospitalization for any medical procedure through Day 28.\n* Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit.\n* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).\n* Known history of any of the following abnormalities in the following clinical laboratory tests (within 6 months prior to the screening visit):\n* Total bilirubin ≥2\\*upper limit of normal (ULN) (except for Gilbert's syndrome)\n* Aspartate aminotransferase or alanine aminotransferase ≥3\\*ULN\n* Suspected or confirmed COVID-19 unrelated to the current episode within 6 months prior to randomization or, for moderately immunocompromised participants, within 3 months prior to randomization.\n* Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.\n* Ongoing long COVID-19 or post-acute sequelae of COVID-19 diagnosis.\n* Current severely immunocompromised conditions.\n* Received any other COVID-19-specific therapies within the following timeframes:\n* Antiviral agents (for example, remdesivir, nirmatorelvir\u002Fritonavir, molnupiravir, ensitrelvir) within 30 days or 5 half-lives (whichever is longer) prior to randomization\n* Anti-SARS-CoV-2 monoclonal antibodies and COVID-19 convalescent plasma within 6 months prior to randomization\n\nNote: Other protocol-define criteria apply","12 Years",{"count":170,"type":22},2000,[26],"The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.",[174],"SARS-CoV-2",[174,176,177,178],"COVID-19","Secutrelvir","S-892216",{"date":42,"type":43},{"date":181,"type":22},"2026-08-31",{"date":183,"type":22},"2028-12-31",{"name":185,"class":50},"Shionogi",27,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":194,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":196,"type":22},7140,[26],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[200,201],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[203,204,205,206],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":40,"type":43},{"date":209,"type":43},"2025-12-01",{"date":211,"type":22},"2031-08",{"name":213,"class":50},"Eli Lilly and Company",567,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"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":224,"type":22},705,[26],"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.",[228],"Multiple Sclerosis (MS) Primary Progressive",{"date":40,"type":43},{"date":231,"type":43},"2026-03-23",{"date":233,"type":22},"2030-07",{"name":235,"class":50},"Zenas BioPharma (USA), LLC",48,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":244,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":259},"100595217","phase-2-phase-2-efficacy-and-safety-study-of-acp-204-in-lewy-body-dementia-psychosis-100595217","NCT07029581","Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis","A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)","Inclusion Criteria:\n\n* Male or female ≥55 years to \\\u003C85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting\n* Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:\n\n  1. The subject's LAR must provide written informed consent.\n  2. The subject must provide written (if capable) informed assent per local regulations.\n* Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).\n* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association\n\nExclusion Criteria:\n\n* Is in hospice, is receiving end-of-life palliative care, or is bedridden\n* Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia\n* Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)\n* Has a history or current evidence of a serious and\u002For significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures\n* Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT","55 Years","84 Years",{"count":247,"type":22},180,[25],"Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.",[251],"Lewy Body Dementia Psychosis",{"date":40,"type":43},{"date":254,"type":43},"2025-08-06",{"date":256,"type":22},"2028-03",{"name":258,"class":50},"ACADIA Pharmaceuticals Inc.",60,{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":59,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":281,"locationsCount":283},"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":269,"type":22},645,[25],"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.",[273,274,275,276],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":42,"type":43},{"date":279,"type":43},"2025-05-27",{"date":256,"type":22},{"name":282,"class":50},"Spyre Therapeutics, Inc.",267,{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":293,"type":22},15100,[26],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[297],"Cardiovascular Disease",[299],"Atherosclerotic Cardiovascular Disease",{"date":40,"type":43},{"date":302,"type":43},"2025-06-04",{"date":304,"type":22},"2029-10-26",{"name":159,"class":50},1452,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100587610","phase-3-a-study-to-assess-the-efficacy-and-safety-of-debio-4126-in-participants-with-acromegaly-previously-treated-with-somatostatin-analogs-100587610","NCT06930625","A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs","A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs","OXTEND™-03","Inclusion criteria\n\n1. Patients ≥18 years of age\n2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.\n3. IGF-1 at screening ≤1x ULN\n4. Acromegaly diagnosis, defined as per protocol\n5. Adequate bone marrow, hepatic and renal function\n6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication\n7. Other protocol-defined criteria apply\n\nExclusion criteria\n\n1. Compression of optic chiasm causing visual defects\n2. Symptomatic cholelithiasis or bile duct dilatation\n3. Planned cholecystectomy during the trial duration\n4. Acute or chronic pancreatitis\n5. Pituitary radiotherapy\n6. Uncontrolled hypothyroidism\n7. Uncontrolled diabetes\n8. Pituitary surgery within 6 months before screening or planned on trial\n9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening\n10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism\n11. Other protocol-defined criteria apply",{"count":316,"type":22},119,[26],"The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.",[320],"Acromegaly",[322,323,324,325],"IGF-1","Growth hormone","Pituitary gland","Gigantism",{"date":40,"type":43},{"date":328,"type":43},"2025-11-26",{"date":330,"type":22},"2029-03",{"name":332,"class":50},"Debiopharm International SA",73,{"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":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":355},"100569788","phase-3-a-study-to-understand-how-the-study-medicine-dazukibart-works-in-people-with-idiopathic-inflammatory-myopathies-100569788","NCT06698796","A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies","A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)","Inclusion Criteria:\n\n* Participants that completed a qualifying study through Week 52.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation.\n* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).\n* Current use of any prohibited concomitant medication(s).\n* Active bacterial, viral, fungal, mycobacterial or other infections.\n* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.\n* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.",{"count":342,"type":22},211,[26],"The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \\[DM\\] or polymyositis \\[PM\\]).\n\nIdiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.\n\nDM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.\n\nThese disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.\n\nThis study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.\n\nThe study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.\n\nThere will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.",[346,347],"Dermatomyositis","Polymyositis",{"date":42,"type":43},{"date":350,"type":43},"2025-01-22",{"date":352,"type":22},"2031-07-29",{"name":354,"class":50},"Pfizer",26,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":168,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":373,"locationsCount":374},"100542140","phase-3-a-study-of-lebrikizumab-ly3650150-in-participants-with-chronic-rhinosinusitis-and-nasal-polyps-treated-with-intranasal-corticosteroids-contrast-np-100542140","NCT06338995","A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab\u002FLY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids","Inclusion Criteria:\n\n* Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).\n* Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.\n* Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.\n* Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:\n\n  1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and\n  2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.\n* Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.\n* Adolescent participants ≥12 to \\\u003C18 years of age and weighing ≥40 kg at time of Visit 1.\n\nExclusion Criteria:\n\n* Have received a dose of lebrikizumab.\n* Have received treatment with any rescue medication and\u002For have the need for surgery for NP during screening and\u002For run-in period.\n* Allergen immunotherapy (subcutaneous immunotherapy \\[SCIT\\]\u002Fsublingual immunotherapy \\[SLIT\\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).\n* Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.\n* Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:\n\n  1. B cell-depleting biologics, including rituximab, within 6 months.\n  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.\n  3. Systemic immunosuppressants within 4 weeks prior to baseline.\n* Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening\n* Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS\n* Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:\n\n  1. Nasal septal deviation occluding at least one nostril.\n  2. Antrochoanal polyps.\n  3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.\n  4. Ongoing rhinitis medicamentosa.\n  5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.\n  6. A nasal cavity tumor (malignant or benign).\n  7. Evidence of fungal rhinosinusitis.\n* Have anosmia from COVID or any reason other than CRSwNP.\n* Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.\n* Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.",{"count":364,"type":22},510,[26],"The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.",[368],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",{"date":40,"type":43},{"date":371,"type":43},"2024-04-29",{"date":256,"type":22},{"name":213,"class":50},202,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n    1. Basal or squamous cell carcinoma of the skin;\n    2. Carcinoma in situ of the cervix;\n    3. Carcinoma in situ of the breast; and\u002For\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":384,"type":22},324,[26],"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[388,389],"Myelofibrosis","Anemia",[391,392],"TAK-226","Drug therapy","2026-08-20",{"date":40,"type":43},{"date":396,"type":22},"2026-09-02",{"date":398,"type":22},"2034-03-30",{"name":400,"class":50},"Takeda",195,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":409,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100610646","phase-2-study-of-abbv-142-to-assess-adverse-events-and-change-in-disease-activity-in-adult-participants-with-idiopathic-pulmonary-fibrosis-100610646","NCT07230288","Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis","A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n\\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.\n\nExclusion Criteria:\n\n* History of stroke within 6 months prior to screening\n* In the opinion of the investigator, other clinically significant pulmonary abnormalities\n* History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.","40 Years",{"count":411,"type":22},165,[25],"Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1).\n\nABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is \"double-blind\", meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world.\n\nParticipants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[415],"Idiopathic Pulmonary Fibrosis",[415],{"date":40,"type":43},{"date":419,"type":43},"2026-01-23",{"date":421,"type":22},"2029-09",{"name":423,"class":50},"AbbVie",49,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100605631","phase-3-a-master-protocol-of-multiple-agents-in-adults-with-metabolic-dysfunction-associated-steatotic-liver-disease-synergy-outcomes-100605631","NCT07165028","A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)","A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes","Inclusion Criteria:\n\n* Have liver fat content ≥8%\n* Have ELF score of ≥9 and ≤10.8 at screening\n* Have VCTE LSM ≥10 kilopascal (kPa) and \\\u003C20 kPa at screening\n\nExclusion Criteria:\n\n* Have any other type of liver disease other than MASLD\n* Have a body mass index (BMI) \\\u003C25 kilogram per square meter (kg\u002Fm2)\n* Prior decompensated liver disease (history of esophageal\u002Fgastric varices, ascites, hepatic encephalopathy)\n* Have lost more than 11 pounds within the 3 months prior to screening\n* Have a hemoglobin A1c (HbA1c) greater than 10%\n* Have type 1 diabetes",{"count":433,"type":22},4500,[26],"The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.\n\nOnce the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.",[437],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[439,440,441,442,443,444,445,446,447,448,449,450,451,452],"Nonalcoholic Steatohepatitis","NASH","Fatty Liver","Fatty Liver Disease","SLD","Metabolic Dysfunction-Associated Fatty Liver Disease","MAFLD","Non-alcoholic Fatty Liver Disease","NAFLD","Hepatic Steatosis","Liver Related Outcomes","GLP1","Incretin","Non-Invasive Test",{"date":152,"type":43},{"date":455,"type":43},"2025-10-15",{"date":457,"type":22},"2032-08",{"name":213,"class":50},565,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":409,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":484},"100601935","phase-3-long-term-safety-study-of-deucravacitinib-versus-ustekinumab-in-participants-with-psoriasis-pragmatyk-100601935","NCT07116967","Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)","A Phase 3b\u002F4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Participants with moderate-to-severe plaque psoriasis:\n\n  1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;\n  2. Have at least 1 of the following cardiovascular risk factors:\n* Current cigarette smoker\n* Diagnosis of hypertension\n* Diagnosis of hyperlipidemia\n* Diabetes mellitus type 1 or 2\n* History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack\n* Obesity\n* Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.\n\nExclusion Criteria:\n\n* Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.\n* Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.\n* Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).\n* Other protocol define inclusion\u002Fexclusion criteria apply.",{"count":468,"type":22},3040,[26],"A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis",[472],"Plaque Psoriasis",[474,475,476,477],"Deucravacitinib","Plaque psoriasis","Cardiovascular risk","PRAGMATYK",{"date":152,"type":43},{"date":480,"type":43},"2025-09-22",{"date":482,"type":22},"2031-01-16",{"name":49,"class":50},402,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":508},"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":494,"type":22},160,[26],"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",[498,499,500],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy",{"date":152,"type":43},{"date":503,"type":43},"2025-09-16",{"date":505,"type":22},"2031-01-23",{"name":507,"class":50},"argenx",78,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":518,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":517,"type":22},162,[25],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[498],[498,67,522,523,499,72],"Monoclonal antibody","Human immunoglobulin G1 (IgG1)",{"date":152,"type":43},{"date":526,"type":43},"2025-03-18",{"date":528,"type":22},"2030-05",{"name":79,"class":50},141,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":545,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":560},"100592131","phase-2-a-study-to-learn-about-the-medicine-ponsegromab-in-adults-with-cancer-of-the-pancreas-which-has-spread-and-caused-significant-body-weight-loss-and-fatigue-100592131","NCT06989437","A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue","A Phase 2b\u002F3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma","Key inclusion Criteria:\n\n* Signed Informed Consent Document\n* Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma\n* Cachexia defined by Fearon criteria of weight loss\n* Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy\n* ECOG PS ≤1 with life expectancy of at least 4 months\n\nKey Exclusion Criteria:\n\n* Current active reversible causes of decreased food intake\n* Cachexia caused by other reasons\n* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification\n* Left ventricular ejection fraction \\\u003C50%\n* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody\n* History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients\n* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases\n* Inadequate liver function\n* Renal disease requiring dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2",{"count":539,"type":22},982,[25,26],"Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.",[543,544],"Cachexia","Metastatic Pancreatic Ductal Adenocarcinoma",[546,547,548,549,550,551,552,553],"pancreatic cancer","metastatic cancer","cancer","anorexia","cachexia","weight loss","loss of appetite","fatigue",{"date":40,"type":43},{"date":556,"type":43},"2025-10-03",{"date":558,"type":22},"2029-12-10",{"name":354,"class":50},220,{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100588108","phase-3-mirikizumab-and-tirzepatide-administered-in-adult-participants-with-moderately-to-severely-active-crohns-disease-and-obesity-or-overweight-100588108","NCT06937099","Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","COMMIT-CD","Inclusion Criteria:\n\n* Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD\n* Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg\u002Fm²), or overweight (BMI ≥27 kg\u002Fm2 to \\\u003C30 kg\u002Fm²) and in the presence of at least 1 weight-related comorbid conditions:\n\n  * hypertension\n  * Type 2 diabetes mellitus (T2DM)\n  * dyslipidemia\n  * obstructive sleep apnea, or\n  * cardiovascular disease.\n* Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.\n* Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.\n* Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.\n* Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy\n\nExclusion Criteria:\n\n* Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.\n* Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.\n* Currently have or are suspected to have an abscess.\n* Have a stoma, ileoanal pouch, or ostomy.\n* Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.\n* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.\n* Have a history of severe hypoglycemia and\u002For hypoglycemia unawareness within the 6 months prior to screening.\n* Have had more than 5% body weight change in the past 3 months\n* Have a current or recent acute, active infection.","70 Years",{"count":571,"type":22},290,[26],"The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.\n\nThe maximum duration of this study is up to 61 weeks.",[575,147],"Crohn's Disease",{"date":152,"type":43},{"date":578,"type":43},"2025-06-26",{"date":580,"type":22},"2028-05",{"name":213,"class":50},184,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":569,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":598,"leadSponsor":600,"locationsCount":601},"100588107","phase-3-mirikizumab-administered-at-the-same-time-as-tirzepatide-in-adult-participants-with-moderately-to-severely-active-ulcerative-colitis-and-obesity-or-overweight-phase-3b-study-100588107","NCT06937086","Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study","A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight","COMMIT-UC","Inclusion Criteria:\n\n* Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.\n* Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.\n* Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.\n* Have obesity, \\[body mass index (BMI) 30 kilograms per meter squared (kg\u002Fm2)\\]\n* Have overweight (BMI ≥27 kg\u002Fm2 to \\\u003C30 kg\u002Fm2) and in the presence of at least 1 of these weight-related comorbid conditions:\n\n  * hypertension\n  * Type 2 Diabetes Mellitus (T2DM)\n  * dyslipidemia\n  * obstructive sleep apnea, or\n  * cardiovascular disease.\n* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and\u002For who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.\n\nExclusion Criteria:\n\n* Have a current diagnosis of:\n\n  * Crohn's disease\n  * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis.\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery.\n* Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.\n* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.\n* Have a history of severe hypoglycemia and\u002For hypoglycemia unawareness within the 6 months prior to screening.\n* Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.\n* Have a current or recent acute, active infection.",{"count":592,"type":22},350,[26],"The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.\n\nParticipation in this study will last up to 61 weeks, including 52 weeks of treatment.",[273,147],{"date":152,"type":43},{"date":578,"type":43},{"date":599,"type":22},"2028-04",{"name":213,"class":50},188,{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100587975","phase-3-a-study-to-test-whether-vicadrostat-bi-690517-in-combination-with-empagliflozin-helps-people-with-heart-failure-and-a-weak-pumping-function-of-the-left-side-of-the-heart-100587975","NCT06935370","A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) \u003C 40%","Inclusion criteria:\n\n1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n3. Male or female participants. 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. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\\u003C 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local\u002Finternational guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.\n2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.\n3. Receiving the following treatments:\n\n   * A direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)\n5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.",{"count":610,"type":22},4200,[26],"This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat\u002Fempagliflozin tablets, and the other group takes placebo\u002Fempagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[614],"Heart Failure",{"date":152,"type":43},{"date":617,"type":43},"2025-05-20",{"date":619,"type":22},"2029-02-22",{"name":621,"class":50},"Boehringer Ingelheim",589,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":643},"100566436","phase-2-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-ph20-sc-in-adults-with-systemic-sclerosis-100566436","NCT06655155","A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis","A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis","eSScape","Inclusion Criteria:\n\n* Is aged ≥18 years and the local legal age of consent for clinical studies\n* Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR\u002FEULAR classification criteria\n* Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160\n* Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3\n* Has a modified Rodnan Skin Score (mRSS) score between 15 and 35\n* The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening\n* Has uninvolved or mildly thickened skin area in at least 1 injection site\n\nExclusion Criteria:\n\n* Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory\n* Significant Pulmonary Arterial Hypertension\n* Severe digital vasculopathy within the past 3 months\n* Skin thickening due to scleroderma mimics or localized scleroderma\n* Scleroderma renal crisis within the past 6 months of participating to the study\n* Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia",{"count":632,"type":22},81,[25],"The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.\n\nMore information can be found on: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fesscape",[636],"Systemic Sclerosis (SSc)",{"date":152,"type":43},{"date":639,"type":43},"2024-11-11",{"date":641,"type":22},"2027-09",{"name":507,"class":50},77,""]