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, 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Subcutaneous injection
Subcutaneous injection
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial.
Change from baseline in the stimulated whole salivary flow at Week 48.
Time frame: Week 48
To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial.
Change from baseline in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score at Week 48
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48
Change from baseline in the physician's global assessment of disease activity (Physician GDA) score at Week 48
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score at Week 48
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Arizona Arthritis & Rheumatology Associates P.C.
Chandler, Arizona, United States
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Flagstaff, Arizona, United States
RECRUITINGArizona Arthritis & Rheumatology Associates, PLLC
Glendale, Arizona, United States
RECRUITINGArizona Arthritis & Rheumatology Associates P.C.
Phoenix, Arizona, United States
RECRUITINGArizona Arthritis & Rheumatology Associates, P.C.
Tucson, Arizona, United States
RECRUITINGWallace Rheumatic Study Center
Beverly Hills, California, United States
RECRUITINGDenver Arthritis Clinic
Denver, Colorado, United States
RECRUITINGTekton Research
Fort Collins, Colorado, United States
RECRUITINGClinical Research of West Florida, Inc.
Tampa, Colorado, United States
RECRUITINGClinical Research of West Florida - Corporate
Clearwater, Florida, United States
RECRUITING...and 33 more locations
Time frame: Week 48
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the participant's global assessment of disease activity (Patient GDA) at Week 48.
Change from baseline in the participant's global assessment of disease activity (Patient GDA) at Week 48.
Time frame: Week 48