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

• Status: Not yet recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RemeGen Co., Ltd.

Criteria

Main Inclusion Criteria:

1. Written informed consent provided.

2. Males and females, 18-70 years of age.

3. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016).

4. Anti-SSA antibody tested positive at screening.

5. ESSDAI score ≥ 5 at screening.

Main Exclusion Criteria:

1. Secondary Sjogren's syndrome.

2. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR < 60 ml/min, serum creatinine > 2 mg/dL, or proteinuria > 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC < 60% or DLCO < 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma.

3. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening.

4. Received live vaccine within 28 days prior to randomization.

5. Active hepatitis or history of severe liver diseases.

6. HIV positive.

7. Patients with malignant tumors.

8. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer.

9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.

10. Any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.