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NCT07404865PHASE3Recruiting

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

Vor Biopharma

Start Date

2/26/2026

Completion Date

1/1/2029

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

BIOLOGICAL

Telitacicept

DRUG

Placebo

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Conditions

Primary Sjogren's Disease

Locations

Arizona Arthritis & Rheumatology Associates P.C.

Chandler, Arizona 85225

United States

Arizona Arthritis & Rheumatology Associates P.C.

Flagstaff, Arizona 86001

United States

Arizona Arthritis & Rheumatology Associates, PLLC

Glendale, Arizona 85306

United States

Arizona Arthritis & Rheumatology Associates P.C.

Phoenix, Arizona 85392

United States

Arizona Arthritis & Rheumatology Associates, P.C.

Tucson, Arizona 85704

United States

Wallace Rheumatic Study Center

Beverly Hills, California 90210

United States

Denver Arthritis Clinic

Denver, Colorado 80230

United States

Finlay Medical Research Corp

Green Acres, Florida 33467

United States

Suncoast Clinical Research Inc.

New Port Richey, Florida 34652

United States

Chicago Clinical Research Institute Inc

Chicago, Illinois 60607

United States

Clinical Investigation Specialist

Schaumburg, Illinois 60195

United States

Willow Rheumatology & Wellness

Willowbrook, Illinois 60527

United States

Accurate Clinical Research, Inc.

Lake Charles, Louisiana 70605

United States

Arthritis and Rheumatism Associates

Rockville, Maryland 20850

United States

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania 16635

United States

Rheumatic Disease Associates, Ltd.

Willow Grove, Pennsylvania 19090

United States

Allen Arthritis

Allen, Texas 75013

United States

Arthritis and Rheumatology Research Institute, PLLC

Allen, Texas 75013

United States

Accurate Clinical Research

Baytown, Texas 77521

United States

Novel Research LLC

Bellaire, Texas 77401

United States

Precision Comprehensive Clinical Research Solutions

Euless, Texas 76040

United States

Lone Star Arthritis & Rheumatology

Fort Worth, Texas 76109

United States

Accurate Clinical Research, Inc.

Houston, Texas 77089

United States

R&H Clinical Research Inc.

Katy, Texas 77450

United States

Velocity Clinical Research, Waco

Waco, Texas 76710

United States

Tidewater Clinical Research

Chesapeake, Virginia 23320

United States