VORBIO: RC18G007: Primary Sjogren’s : Phase 3 study

May 20 – December 31, 2026

Study Design

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study in adult patients with active primary Sjögren’s syndrome (pSS). Approximately 250 patients will be randomized in a 1:1 ratio to receive telitacicept 160 mg or placebo.- -weekly subcutaneous dosing

Key Eligibility Criteria

Adults aged ≥18 years
Diagnosis of primary Sjögren’s syndrome per 2016 ACR/EULAR classification criteria
Positive anti-SSA/Ro antibody at screening

Mechanism of Action

Telitacicept is a fully human recombinant TACI-Fc fusion protein that targets and neutralizes both B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). By blocking the interaction of BLyS and APRIL with their receptors (TACI, BCMA, and BAFF-R), telitacicept inhibits B-cell survival and differentiation into immunoglobulin-producing plasma cells. This results in reduced autoreactive B cells and autoantibody production, addressing key pathogenic mechanisms underlying primary Sjögren’s syndrome.