Phase 3 Randomized Study of Telitacicept Versus Placebo in Adults With Active Primary Sjogrens Disease

What this Trial Is About

Researchers are evaluating Telitacicept, a recombinant fusion protein, in adults with active primary Sjogrens Disease, an autoimmune condition characterized by B-cell hyperactivity and autoantibody production. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of Telitacicept by modulating B-cell-mediated immune pathways through inhibiting BLyS and APRIL signaling, which are involved in disease activity. Participants will receive either Telitacicept or a placebo through subcutaneous injections as part of a parallel study design. The trial compares these two groups over a treatment period lasting 48 weeks, focusing on changes from baseline in disease activity and related symptoms. Telitacicept binds specific cytokines to reduce B-cell survival and autoantibody production, potentially impacting disease manifestations. During the study, participants will undergo assessments including the EULAR Sjogrens Syndrome Disease Activity Index ESSDAI, glandular function tests, patient- and physician-reported outcomes, and fatigue evaluations. Safety and efficacy will be monitored through these measures at Week 48. The trial spans from screening through treatment and follow-up, with a planned completion by January 2029.

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