A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants with Active Primary Sjögren’s Disease

Condition studied

Active Primary Sjögren’s Disease

Investigational medicinal product(s)

Every trial of Telitacicept across our registers →

Eligibility

Primary endpoint

Change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 48.

Endpoint detail

• Proportion of participants whose ESSDAI score decreased from baseline by ≥ 3 at Week 48. • Proportion of participants whose ESSDAI score is < 5 at Week 48. • Change from baseline in ClinESSDAI score at Week 48. • Change from baseline in the physician’s global assessment of disease activity (Physician GDA) score at Week 48., • Change from baseline in the stimulated whole salivary flow at Week 48. • Change from baseline in the unstimulated whole salivary flow at Week 48. • Change from baseline in Schirmer’s test at all measured time points up to Week 48., • Change from baseline in the following assessments at Week 48: ESSPRI, SF-36, FACIT-F and Patient GDA • Proportion of participants whose ESSPRI score decreased from baseline by ≥ 1 or 15% at Week 48., • Proportion of participants who have a response on at least 3 domains in Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS) score at Week 48. • Proportion of participants who score at least 5 points in Sjögren’s Tool for Assessing Response (STAR) at Week 48.