A Phase Ⅲ, Multi-center, Randomized, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Subcutaneous Telitacicept in Subjects With Active Primary Sjogren's Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 78
- 主要终点
- Change from baseline in ESSDAI score
研究概览
简要总结
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.
详细描述
This is a phase Ⅲ, multi-center, randomized, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent provided.
- •Males and females, 18-70 years of age.
- •Fulfilled the classification criteria of pSS according to ACR/EULAR (2016).
- •Anti-SSA antibody tested positive at screening.
- •ESSDAI score ≥ 5 at screening.
排除标准
- •Secondary Sjogren's syndrome.
- •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.
- •Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening.
- •Received live vaccine within 28 days prior to randomization.
- •Active hepatitis or history of severe liver diseases.
- •HIV positive.
- •Patients with malignant tumors.
- •Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer.
- •Nursing or pregnant female, or male or female who prepared for parenthood during the study.
- •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.
研究组 & 干预措施
Telitacicept 80 mg
Subjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.
干预措施: Telitacicept 80 mg (Biological)
Telitacicept 160 mg
Subjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.
干预措施: Telitacicept 160 mg (Biological)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in ESSDAI score
时间窗: Week 24
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.
次要结局
- Percentage of subjects with ESSPRI score decreased from baseline by at least 1 point or 15%(Week 24 & Week 48)
- Incidence of AEs, SAEs(Up to Week 48)
- Percentage of subjects with ESSDAI score decreased from baseline by at least 3 points(Week 24 & Week 48)
- Percentage of subjects with ESSDAI score < 5(Week 24 & Week 48)
- Change from baseline in MFI-20(Week 24 & Week 48)
- Change from baseline in ESSDAI score(Week 48)