[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sjogrens-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sjogrens-disease":48},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100624071","phase-3-phase-3-study-of-telitacicept-in-active-primary-sjgrens-disease-100624071",false,"NCT07404865","Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease","UPSTREAM SjD","Inclusion Criteria:\n\n1. Male or female aged 18 to 75 years of age (both inclusive) at screening\n2. Participants must meet the 2016 American College of Rheumatology (ACR)\u002FEULAR classification criteria for primary Sjogren's Syndrome at the time of screening.\n3. ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)\n4. Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)\u002FAnti-Sjogren's Syndrome A (Ro) at the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol\n\nExclusion Criteria:\n\n1. Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjogren's Disease)\n2. Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's Disease to therapy (e.g., systemic sclerosis, inflammatory bowel disease, gout).\n3. Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy\n4. Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation\n5. Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma, cardiovascular disease, accelerated hypertension, major depression, etc.) that in the opinion of the investigator would preclude participant participation.\n\nAdditional exclusion criteria are defined in the protocol","ALL","18 Years","75 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)",[28],"Primary Sjogren's Disease",[30,31,32,33,34],"Sjögren's Disease","pSD","Primary Sjogren's Syndrome","Sjogren's Syndrome","SjD","RECRUITING","2026-06-02",{"date":38,"type":39},"2026-06-04","ACTUAL",{"date":41,"type":39},"2026-02-26",{"date":43,"type":22},"2029-01",{"name":45,"class":46},"Vor Biopharma","INDUSTRY",26,"Primary Sjogrens Disease"]