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Telitacicept for active primary Sjögren's disease (Phase 3)

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

PHASE3 · Vor Biopharma · NCT07404865

This trial will test whether telitacicept helps adults with active, antibody-positive primary Sjögren's disease reduce disease activity compared with placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorVor Biopharma (industry)
Locations18 sites (Chandler, Arizona and 17 other locations)
Trial IDNCT07404865 on ClinicalTrials.gov

What this trial studies

Telitacicept is a fusion protein that soaks up the B-cell survival factors BLyS (BAFF) and APRIL to reduce B-cell activity and autoantibody production. In this Phase 3, randomized, placebo-controlled study adults with active primary Sjögren's (ESSDAI ≥5 and SSA/Ro positive) receive telitacicept or placebo and are followed for changes in disease activity and safety. The trial excludes patients with other systemic autoimmune diseases that better explain symptoms and other inflammatory conditions that could confound response. Study sites are limited to clinics in Arizona and procedures include clinical disease activity scoring and laboratory monitoring.

Who should consider this trial

Good fit: Adults aged 18–75 who meet the 2016 ACR/EULAR criteria for primary Sjögren's, are SSA/Ro antibody–positive, and have moderate-to-high disease activity (ESSDAI ≥5) are the intended participants.

Not a fit: People with secondary Sjögren's (another autoimmune disease that better explains symptoms), those who are SSA/Ro–negative, or those with low disease activity are less likely to benefit from this trial.

Why it matters

Potential benefit: If successful, telitacicept could reduce B-cell–driven inflammation and symptoms in people with active primary Sjögren's disease and lower autoantibody levels.

How similar studies have performed: Other drugs targeting the BLyS/APRIL pathway have shown benefit in autoimmune diseases, and earlier-phase studies of telitacicept have reported promising signals, but phase 3 evidence in primary Sjögren's is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female aged 18 to 75 years of age (both inclusive) at screening
2. Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening.
3. ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
4. 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

Exclusion Criteria:

1. 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)
2. 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).
3. Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
4. Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
5. 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

Chandler, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Sjogren's Disease, Sjögren's Disease, pSD, Primary Sjogren's Syndrome, Sjogren's Syndrome, SjD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.