RecruitingPhase 3NCT07404865
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
Sponsor
Vor Biopharma
Enrollment
250 participants
Start Date
Feb 26, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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.
Interventions
BIOLOGICALTelitacicept
Subcutaneous injection
DRUGPlacebo
Subcutaneous injection
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07404865