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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Arthritis & Rheumatology Associates P.C.
  Chandler, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates P.C.
  Flagstaff, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates, PLLC
  Glendale, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates P.C.
  Phoenix, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates, P.C.
  Tucson, Arizona, United States Recruiting
• Wallace Rheumatic Study Center
  Beverly Hills, California, United States Recruiting

Study contacts

• Study coordinator: Jeremy Sokolove
• Email: Study@vorbio.com
• Phone: 6176556580

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.