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Phase 3Recruiting

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

Sponsored by Vor Biopharma

About this study

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

Telitacicept (RC18) is a recombinant fusion protein designed to target B-cell-mediated immune pathways. It consists of the extracellular domain of transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) linked to the Fc portion of human immunoglobulin G1 (IgG1). Telitacicept binds with high affinity to the cytokines B-lymphocyte stimulator (BLyS, also known as BAFF) and A Proliferation-Inducing Ligand (APRIL). By binding these soluble factors, telitacicept prevents their interaction with cell-surface receptors on B cells, including TACI, B-cell maturation antigen (BCMA), and BAFF receptor (BAFF-R). This inhibition reduces BLyS/APRIL signaling, leading to decreased B-cell survival, reduced differentiation of B cells into immunoglobulin-producing plasma cells…

Where this study is enrolling (5)

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Tucson, Arizona

    Call (480) 443-8400

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  • Arizona Arthritis & Rheumatology Associates, PLLC

    Glendale, Arizona

    Call (480) 443-8400

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  • Arizona Arthritis & Rheumatology Associates P.C.

    Chandler, Arizona

    Call (480) 443-8400

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  • Arizona Arthritis & Rheumatology Associates P.C.

    Phoenix, Arizona

    Call (480) 443-8400

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  • Clinical Investigation Specialist

    Schaumburg, Illinois

    Call 262-925-1280

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.