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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 October 2024
• Main ID: NCT05673993
• Date of registration: 29/12/2022
• Prospective Registration: Yes
• Primary sponsor: RemeGen Co., Ltd.
• Public title: A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
• Scientific title: A Phase ?, Multi-center, Randomized, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Subcutaneous Telitacicept in Subjects With Active Primary Sjogren's Syndrome
• Date of first enrolment: April 6, 2023
• Target sample size: 381
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05673993
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Key inclusion & exclusion 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.


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjogren's Syndrome

Intervention(s)

Biological: Telitacicept 80 mg

Biological: Telitacicept 160 mg

Drug: Placebo

Primary Outcome(s)

Change from baseline in ESSDAI score [Time Frame: Week 24]

Secondary Outcome(s)

Change from baseline in MFI-20 [Time Frame: Week 24 & Week 48]

Change from baseline in ESSDAI score [Time Frame: Week 48]

Percentage of subjects with ESSDAI score decreased from baseline by at least 3 points [Time Frame: Week 24 & Week 48]

Percentage of subjects with ESSDAI score < 5 [Time Frame: Week 24 & Week 48]

Incidence of AEs, SAEs [Time Frame: Up to Week 48]

Percentage of subjects with ESSPRI score decreased from baseline by at least 1 point or 15% [Time Frame: Week 24 & Week 48]

Secondary ID(s)

18C022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors