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

RemeGen Co., Ltd.381 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

381

Conditions

Primary Sjogren's Syndrome

Interventions

Telitacicept 80 mgBIOLOGICAL

Telitacicept 80 mg subcutaneously once a week.

Telitacicept 160 mgBIOLOGICAL

Telitacicept 160 mg subcutaneously once a week.

PlaceboDRUG

Subjects will be given subcutaneous placebo once a week.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (78)

Outcomes

Primary Outcomes

Change from baseline in ESSDAI score

The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.

Time frame: Week 24

Secondary Outcomes

Change from baseline in ESSDAI score

Time frame: Week 48

Percentage of subjects with ESSDAI score decreased from baseline by at least 3 points

Data from ClinicalTrials.gov

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