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