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

NCT05673993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Primary Sjogren's Syndrome

Interventions

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.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05673993 on ClinicalTrials.gov