RecruitingPhase 3

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

United States250 participantsStarted 2026-02-26

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.

Timeframe: Week 48

Trial details

NCT IDNCT07404865

SponsorVor Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Jeremy Sokolove

6176556580 Study@vorbio.com

View on ClinicalTrials.gov More Primary Sjogren's Disease trials