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NCT07404865 | RECRUITING | Primary Sjogren's Disease

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

Vor Biopharma

Brief Summary:

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

Condition or disease

Primary Sjogren's Disease

Intervention/treatment

Telitacicept

Placebo

Phase

PHASE3

Detailed Description:

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, and lowering of autoantibody production, increased BLyS and APRIL levels, B-cell hyperactivity, and autoantibody production are associated with multiple autoimmune diseases. Modulation of the BLyS/APRIL pathway is intended to reduce pathogenic B-cell activity and downstream immune effects that contribute to disease manifestations in Sjogren's disease and other B-cell-mediated autoimmune conditions.

Study Type : INTERVENTIONAL
Estimated Enrollment : 250 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2026-02-26
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2029-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease

Location Details

NCT07404865

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

Chicago Clinical Research Institute Inc

Chicago, Illinois, United States, 60607

RECRUITING

United States, Louisiana

Accurate Clinical Research, Inc.

Lake Charles, Louisiana, United States, 70605

RECRUITING

United States, Texas

Novel Research LLC

Bellaire, Texas, United States, 77401

RECRUITING

United States, Texas

Accurate Clinical Research, Inc.

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

Velocity Clinical Research, Waco

Waco, Texas, United States, 76710