[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635077":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":25,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GenSci048 group","EXPERIMENTAL","GenSci048 high-dose administered subcutaneously (SC) according to the protocol.",[13],"Drug: GenSci048",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo","Administered SC every 4 weeks.",[18],"Drug: Placebo",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","GenSci048","Administered SC.",[9],null,{"type":21,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Jingsi Li","CONTACT","+86 18301941524","lijingsi@genscigroup.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Eye & Ent Hospital of Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200031","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":25,"email":53},"Peizeng Yang, Doctor","023-89012851","Peizengyang@126.com",{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"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 while receiving a stable dose of oral prednisone maintenance therapy for at least 2 weeks;\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 baseline visits;\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 to anti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded) within 12 weeks prior to baseline visit;","ALL","18 Years",{"count":66,"type":67},74,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.",[73],"Uveitis","2026-07-22",{"date":76,"type":77},"2026-07-24","ACTUAL",{"date":79,"type":77},"2026-06-29",{"date":81,"type":67},"2028-01-13",{"name":5,"class":6},1]