[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stills-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stills-disease":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100608549","phase-2-a-phase-ii-trial-to-evaluate-the-clinical-efficacy-safety-and-tolerability-of-mas825-in-pediatric-and-adult-participants-with-stills-disease-100608549",false,"NCT07203001","A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease","An Open-label Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease","Inclusion Criteria:\n\n* Age ≥ 1 with a diagnosis of Still's Disease\n* Active diseases defined as:\n* CRP or ferritin levels greater than ULN, and any of:\n\n  * Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or\n  * Rash attributed to Still's Disease activity or\n  * Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or\n  * Serositis or\n  * Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator\n* Intolerance or inadequate response to available biologic therapy\n\nExclusion Criteria:\n\n* Patients out of weight range\n* Ongoing or previous treatment with immunomodulatory drugs\n\n  * A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study\n* Glucocorticoid dose exceeding a set limit\n* Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy\n\n  * Still's disease patients with evidence of macrophage activation syndrome are permitted in the study\n  * Still's Disease patients with evidence of interstitial lung disease including those requiring supplemental oxygen therapy are permitted in the study\n* History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and\u002For symptoms and signs of clinically significant active bacterial, fungal or viral infections\n* Live vaccinations within a set time prior to MAS825 treatment. Live vaccines are prohibited up to several months following the last dose\n* History of malignancy of any organ system, including post-transplant lymphoproliferative disorder, treated or untreated, within a number of years, regardless of whether there is evidence of local recurrence and metastases\n* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients\n* Pregnant or breastfeeding women\n* Women of child-bearing potential who do not agree to comply with required contraceptive use\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","1 Year",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease",[26],"Still´s Disease",[28,29,30,31,32,33,34,35,36,37],"Still´s disease","pediatric","adult","sJIA","AOSD","Systemic Juvenile Idiopathic Arthritis","Adult Onset Still s disease","rheumatology","MAS825","arumakimig","RECRUITING","2026-08-18",{"date":41,"type":42},"2026-08-19","ACTUAL",{"date":44,"type":42},"2025-11-03",{"date":46,"type":20},"2028-05-17",{"name":48,"class":49},"Novartis Pharmaceuticals","INDUSTRY",23,"Still's Disease"]