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)

Chicago Clinical Research Institute Inc

Chicago, Illinois, United States

Accurate Clinical Research, Inc.

Lake Charles, Louisiana, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07404865