Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Recruiting now Phase 3 NCT07404865
Run by Vor Biopharma · for 18 to 75 · All sexes
What this study is about
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Who can join (things the study team will check)
✅ You may be able to join if…
- Male or female aged 18 to 75 years of age (both inclusive) at screening
- Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
- ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
- Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit. Additional inclusion criteria are defined in the protocol
🚫 You may not be able to join if…
- 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)
- 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).
- Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
- Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
- 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. Additional exclusion criteria are defined in the protocol
Where this trial is running
- Arizona Arthritis & Rheumatology Associates P.C., Chandler, Arizona, United States
- Arizona Arthritis & Rheumatology Associates P.C., Flagstaff, Arizona, United States
- Arizona Arthritis & Rheumatology Associates, PLLC, Glendale, Arizona, United States
- Arizona Arthritis & Rheumatology Associates P.C., Phoenix, Arizona, United States
- Arizona Arthritis & Rheumatology Associates, P.C., Tucson, Arizona, United States
- Wallace Rheumatic Study Center, Beverly Hills, California, United States
- Denver Arthritis Clinic, Denver, Colorado, United States
- Tekton Research, Fort Collins, Colorado, United States
- Clinical Research of West Florida, Inc., Tampa, Colorado, United States
- Clinical Research of West Florida - Corporate, Clearwater, Florida, United States
- Clinical Research of West Florida, Inc., Clearwater, Florida, United States
- GNP Research, Cooper City, Florida, United States
+ 31 more sites.
Who to contact
Jeremy Sokolove · 6176556580 · Study@vorbio.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07404865.
Verify everything on the official ClinicalTrials.gov record. Page updated September 2026.
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