[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657357":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":51,"studyPopulation":41,"armGroups":52,"interventions":74,"overallOfficials":41,"centralContacts":91,"locations":97,"responsibleParty":122,"collaborators":41,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":41,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":41,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":41,"overallStatus":143,"whyStopped":41,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24","The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.","Baseline and Week 24",[14,17,21,24,28,31,34,37],{"measure":15,"description":11,"timeFrame":16},"Change from Baseline in ESSDAI Score at Weeks 12 and 48","Baseline to Weeks 12 and 48",{"measure":18,"description":19,"timeFrame":20},"Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48","The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported measure assessing dryness, fatigue, and pain. Each domain is rated on a 0-to-10 numerical rating scale, and the total ESSPRI score is calculated as the mean of the three domain scores, ranging from 0 to 10. Higher scores indicate greater symptom severity. A decrease from baseline indicates improvement.","Baseline to Weeks 12, 24, and 48",{"measure":22,"description":23,"timeFrame":20},"Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48","Stimulated salivary flow rate will be measured according to the protocol-specified procedure. An increase from baseline indicates an improvement in stimulated salivary gland function.",{"measure":25,"description":26,"timeFrame":27},"Change from Baseline in Schirmer Test at Week 48","The Schirmer test is used to assess tear production and is reported as the length of wetting of the test strip over 5 minutes, measured in millimeters (mm\u002F5 min). Higher values indicate greater tear production.","Baseline to Week 48",{"measure":29,"description":30,"timeFrame":27},"Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48","The Sj?gren's Tool for Assessing Response (STAR) is a composite assessment of treatment response in Sj?gren's disease incorporating systemic disease activity, patient-reported symptoms, and biological and glandular domains. Higher scores indicate a greater treatment response.",{"measure":32,"description":33,"timeFrame":20},"Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48","The FACIT-Fatigue scale is a 13-item patient-reported measure of fatigue. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. An increase from baseline indicates improvement.",{"measure":35,"description":36,"timeFrame":20},"Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score at Weeks 12, 24, and 48","The EQ-5D-5L is a standardized measure of health status assessing five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Each dimension has five levels of severity. Responses are converted to an EQ-5D-5L index score using the prespecified value set, with higher index scores indicating better health status.",{"measure":38,"description":39,"timeFrame":40},"Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed throughout the study.","From the first dose of study intervention through Week 48",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":48},"DOUBLE",[49,50],"PARTICIPANT","INVESTIGATOR","This study is a randomized, double-blind, placebo-controlled Phase II study in participants with moderate-to-severe Sjögren's disease. Eligible participants will be randomized to receive IBI355 or placebo during the double-blind treatment period.\n\nThe study will evaluate the efficacy of IBI355 in reducing systemic disease activity and improving patient-reported symptoms and disease-related functional outcomes. Safety and tolerability will be assessed throughout the study. Pharmacokinetic, immunogenicity, pharmacodynamic, and other relevant clinical assessments will also be performed as specified in the protocol.\n\nThe results of this study are intended to characterize the efficacy and safety profile of IBI355 in participants with Sjögren's disease and to support its further clinical development.",[53,60,65,69],{"label":54,"type":55,"description":56,"interventionNames":57},"Part A: IBI355 group","EXPERIMENTAL","IBI355，IV,corresponding dose regimen according to study cohort( Part A) .",[58,59],"Drug: Part A - Placebo for IBI355","Drug: Part A - IBI355",{"label":61,"type":55,"description":62,"interventionNames":63},"Part B: Telitacicept 160 mg group","Participants received telitacicept 160 mg SC QW from Week 0 to Week 24. Follow-up through Week 36",[64],"Drug: Part B -Telitacicept",{"label":66,"type":55,"description":67,"interventionNames":68},"Part A: Placebo group（IBI355-matched）","Matching placebo of IBI355， IV ，corresponding dose regimen according to study design",[58,59],{"label":70,"type":55,"description":71,"interventionNames":72},"Part B: Placebo group (Telitacicept-matched)","Participants received matching placebo SC QW from Week 0 to Week 24. Follow-up through Week 36.",[73],"Drug: PartB -Placebo for Telitacicept",[75,79,83,87],{"type":76,"name":77,"description":67,"armGroupLabels":78,"otherNames":41},"DRUG","Part A - Placebo for IBI355",[54,66],{"type":76,"name":80,"description":81,"armGroupLabels":82,"otherNames":41},"Part B -Telitacicept","Telitacicept 160 mg SC QW × 24 doses (Weeks 0-24).",[61],{"type":76,"name":84,"description":85,"armGroupLabels":86,"otherNames":41},"PartB -Placebo for Telitacicept","Matching placebo of Talitacicept ，SC QW × 24 doses.",[70],{"type":76,"name":88,"description":89,"armGroupLabels":90,"otherNames":41},"Part A - IBI355","IBI355,IV,corresponding dose regimen according to study design",[54,66],[92],{"name":93,"role":94,"phone":95,"phoneExt":41,"email":96},"xiaoyan li","CONTACT","18756032014","xiaoyan.li@innoventbio.com",[98],{"facility":99,"status":41,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"The First Affiliated Hospital of University of Science and Technology of China","Hefei","Anhui","230001","China","CN",{"type":106,"coordinates":107},"Point",[108,109],117.28083,31.86389,{"lat":109,"lon":108},[112,116,119],{"name":113,"role":94,"phone":114,"phoneExt":41,"email":115},"Xiaomei Li","13866795533","lixiaomei@fsmy@aliyun.com",{"name":117,"role":118,"phone":41,"phoneExt":41,"email":41},"Zhen Tan, M.D.","SUB_INVESTIGATOR",{"name":120,"role":121,"phone":41,"phoneExt":41,"email":41},"Xiaomei Li, M.D.","PRINCIPAL_INVESTIGATOR",{"type":123,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100657357","phase-2-a-study-of-ibi355-in-participants-with-moderate-to-severe-sjgrens-disease-100657357",false,"NCT07836660","A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease","Inclusion Criteria：\n\n* Age ≥18 and ≤75 years.\n* Diagnosis of Sjögren's syndrome per 2016 ACR\u002FEULAR classification criteria.\n* Duration of Sjögren's syndrome diagnosis ≤7.5 years.\n* Serum anti-Ro\u002FSSA (Ro60 and\u002For Ro52) positive.\n* Stimulated whole saliva flow rate ≥0.05 mL\u002Fmin at screening.\n* Baseline ESSDAI score ≥5 in ≥1 of the following domains: systemic, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic, biological.\n* Stable background therapy (hydroxychloroquine ≤400 mg\u002Fday, methotrexate ≤25 mg\u002Fweek, or azathioprine ≤150 mg\u002Fday) for ≥12 weeks with stable dose ≥8 weeks prior to randomization.\n* Stable oral corticosteroid dose (≤10 mg\u002Fday prednisone equivalent) for ≥4 weeks prior to randomization.\n\nExclusion Criteria：\n\n* Known hypersensitivity to IBI355 or its excipients.\n* Pregnancy or breastfeeding.\n* Uncontrolled interstitial lung disease (ILD) associated with Sjögren's syndrome (e.g., FVC \\\u003C70% predicted, ClinESSDAI pulmonary domain indicating severe activity, or NYHA Class III\u002FIV dyspnea).\n* Active or untreated latent tuberculosis (IGRA-positive without ≥1 month prophylactic treatment).\n* Chronic hepatitis B (HBsAg+), hepatitis C (HCV RNA+), HIV, or syphilis.\n* Prior use of rituximab, other anti-CD20 agents, or other biologics targeting CD40\u002FCD40L, BAFF\u002FAPRIL, or CTLA-4 within 6 months prior to randomization.\n* Use of JAK\u002FTYK inhibitors within 8 weeks prior to randomization.","ALL","18 Years","75 Years",{"count":135,"type":136},198,"ESTIMATED","INTERVENTIONAL",[139],"PHASE2","This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).",[142],"Sjögren's Disease","NOT_YET_RECRUITING","2026-09-18",{"date":146,"type":147},"2026-09-23","ACTUAL",{"date":149,"type":136},"2026-10-15",{"date":151,"type":136},"2028-10-31",{"name":5,"class":6},1]