NCT05673993

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

A Phase Ⅲ, Multi-center, Randomized, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Subcutaneous Telitacicept in Subjects With Active Primary Sjogren's Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase Ⅲ, multi-center, randomized, double-blind, placebo-controlled study. Subjects with active primary Sjogren's Syndrome (pSS) will be randomized to receive subcutaneous Telitacicept 80 mg, Telitacicept 160 mg or placebo weekly for a total of 48 weeks. Subjects are allowed to be transferred to another group after Week 24 by the investigator so that those randomized to the placebo group are able to receive either Telitacicept 80 mg or Telitacicept 160 mg afterwards. Subjects who are randomized to Telitacicept 80 mg and Telitacicept 160 mg groups will remain in the previous treatment group even if the investigator chooses to transfer them. Subjects and investigators are blinded throughout the study.

Conditions

• Primary Sjogren's Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Telitacicept 80 mg	Telitacicept 80 mg subcutaneously once a week.
BIOLOGICAL	Telitacicept 160 mg	Telitacicept 160 mg subcutaneously once a week.
DRUG	Placebo	Subjects will be given subcutaneous placebo once a week.

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-10-29
• Completion: 2025-05-06
• First posted: 2023-01-06
• Last updated: 2025-10-01

Locations

78 sites across 1 country: China