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

Conditions

• Primary Sjogren's Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Telitacicept 80 mg — BIOLOGICAL
  Telitacicept 80 mg subcutaneously once a week.
• Telitacicept 160 mg — BIOLOGICAL
  Telitacicept 160 mg subcutaneously once a week.
• Placebo — DRUG
  Subjects will be given subcutaneous placebo once a week.

Study Details

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.

Key Dates

Start date

Apr 6, 2023

Status verified

Jun 2025

Primary completion

Oct 29, 2024

Completion

May 6, 2025

Study Design

Enrollment

381 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Telitacicept 80 mg
  Subjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.
• Experimental: Telitacicept 160 mg
  Subjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.
• Placebo Comparator: Placebo
  Subjects will be given subcutaneous placebo once a week for 24-48 weeks. Subjects who are randomized to the placebo group are allowed to be transferred to either Telitacicept 80 mg or Telitacicept 160 mg after Week 24 by the investigator. Subjects and investigators are blinded throughout the study.

Primary Outcome Measure

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