Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Primary Sjogren's Disease

In brief

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)

Key facts

Study ID

NCT07404865

Run by

Vor Biopharma

People needed

250

Starts

2026-02-26

Expected to finish

2029-01-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Arizona Arthritis & Rheumatology Associates P.C. — Chandler, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates P.C. — Flagstaff, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates, PLLC — Glendale, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates P.C. — Phoenix, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates, P.C. — Tucson, Arizona, United States (enrolling)
• Wallace Rheumatic Study Center — Beverly Hills, California, United States (enrolling)
• Denver Arthritis Clinic — Denver, Colorado, United States (enrolling)
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States (enrolling)
• Finlay Medical Research Corp — Green Acres, Florida, United States (enrolling)
• Suncoast Clinical Research Inc. — New Port Richey, Florida, United States (enrolling)
• Bioresearch Partner — South Miami, Florida, United States (enrolling)
• Chicago Clinical Research Institute Inc — Chicago, Illinois, United States (enrolling)
• Clinical Investigation Specialist — Schaumburg, Illinois, United States (enrolling)
• Willow Rheumatology & Wellness — Willowbrook, Illinois, United States (enrolling)
• Accurate Clinical Research, Inc. — Lake Charles, Louisiana, United States (enrolling)
• Arthritis and Rheumatism Associates — Rockville, Maryland, United States (enrolling)
• Altoona Center for Clinical Research, P.C. — Duncansville, Pennsylvania, United States (enrolling)
• Rheumatic Disease Associates, Ltd. — Willow Grove, Pennsylvania, United States (enrolling)
• Allen Arthritis — Allen, Texas, United States (enrolling)
• Arthritis and Rheumatology Research Institute, PLLC — Allen, Texas, United States (enrolling)
• Accurate Clinical Research — Baytown, Texas, United States (enrolling)
• Novel Research LLC — Bellaire, Texas, United States (enrolling)
• Precision Comprehensive Clinical Research Solutions — Euless, Texas, United States (enrolling)
• Lone Star Arthritis & Rheumatology — Fort Worth, Texas, United States (enrolling)
• Accurate Clinical Research, Inc. — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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