drugset / Trial / NCT05673993

A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

NCT05673993 ↗

Phase 3 Completed 381 enrolled RemeGen Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.

Timeline

Start
2023-04-06
Primary completion
2024-10-29
Completion
2025-05-06

Outcome

Met primary endpoint

release “achieved the primary endpoint in a Phase 3 clinical study in China evaluating telitacicept in adults with primary Sjögren's disease.” vorbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Telitacicept Protein / enzyme biologic 80 mg Subcutaneous
Subject Telitacicept Protein / enzyme biologic 160 mg Subcutaneous

Indications