[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635077":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":38,"locations":44,"responsibleParty":58,"collaborators":30,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":30,"enrollmentInfo":69,"targetDuration":30,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":30,"overallStatus":78,"whyStopped":30,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"GenSci048 High-dose group","EXPERIMENTAL","GenSci048 high-dose administered subcutaneously (SC) according to the protocol.",[13],"Drug: GenSci048 High-dose",{"label":15,"type":10,"description":16,"interventionNames":17},"GenSci048 Low-dose group","GenSci048 low-dose administered subcutaneously (SC) according to the protocol.",[18],"Drug: GenSci048 Low-dose",{"label":20,"type":10,"description":21,"interventionNames":22},"Placebo","Administered SC every 4 weeks.",[23],"Drug: Placebo",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","GenSci048 High-dose","High-dose Administered SC.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"GenSci048 Low-dose","Low-dose Administered SC.",[15],{"type":26,"name":20,"description":36,"armGroupLabels":37,"otherNames":30},"Administered SC.",[20],[39],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},"Jingsi Li","CONTACT","+86 18301941524","lijingsi@genscigroup.com",[45],{"facility":46,"status":30,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":30},"Eye & Ent Hospital of Fudan University","Shanghai","Shanghai Municipality","200031","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},{"type":59,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100635077","phase-2-a-study-of-efficacy-and-safety-of-gensci048-in-subjects-with-active-uveitis-100635077",false,"NCT07547995","A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.","A Phase II Clinical Study to Assess the Efficacy and Safety of GenSci048 in Subjects With Active Non-infectious Uveitis.","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis;\n3. Must have active disease at the baseline visit;\n4. Must have demonstrated a prior adequate response to oral corticosteroid therapy (equivalent of oral prednisone up to 1 mg\u002Fkg\u002Fday), as judged by the investigator;\n5. No intention to become pregnant and willingness to use highly effective contraception during the study and for 24 weeks after the last dose of study drug;\n6. Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.\n\nExclusion Criteria:\n\n1. Subjects with isolated anterior uveitis;\n2. Subjects with neovascular\u002Fwet age-related macular degeneration, proliferative or severe non-proliferative diabetic retinopathy, or clinically significant macular edema due to diabetic retinopathy;\n3. Subjects with systemic inflammatory diseases requiring continued treatment with oral corticosteroids or prohibited immunosuppressive agents at screening or baselinevisits;\n4. Any of the following:\n\n   Confirmed active tuberculosis (TB) infection, including but not limited to radiologically confirmed active TB; Subjects with latent TB infection or at high risk for TB may be enrolled, provided they are not considered unsuitable by the investigator (e.g., unwillingness to continue anti-TB treatment per local guidelines after entering the study);\n5. Presence of significant comorbidities, including but not limited to: uncontrolled hypertension (≥200\u002F105 mmHg), congestive heart failure (Stage D), or uncontrolled type 1 or type 2 diabetes (fasting blood glucose \\>7.0 mmol\u002FL or random blood glucose \\>11.1 mmol\u002FL); eligibility will be determined at the discretion of the investigator;\n6. Subject has previous exposure toanti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded);","ALL","18 Years",{"count":70,"type":71},111,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.",[77],"Uveitis","NOT_YET_RECRUITING","2026-04-21",{"date":81,"type":82},"2026-04-23","ACTUAL",{"date":84,"type":71},"2026-06-18",{"date":86,"type":71},"2028-01-13",{"name":5,"class":6},1]