A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- SLE Responder Index (SRI-4)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
详细描述
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.
Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses and may alleviate autoimmune symptoms.
This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-70 years at screening.
- •Has a diagnosis of SLE for at least 6 months prior to the screening visit.
- •Meets the 2019 EULAR/ACR Classification criteria for SLE.
- •Moderately to severely active SLE definined by the following:
- •SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
- •BILAG organ system scores of at least 1A or 2B at screening.
- •Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
- •At least one positive serologic parameter within the screening period.
- •Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
排除标准
- •Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
- •Active or unstable neuropsychiatric SLE.
- •Autoimmune or rheumatic disease other than SLE.
- •History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
- •History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.
研究组 & 干预措施
Telitacicept
Telitacicept + Standard of Care (SOC)
干预措施: Telitacicept (Biological)
Placebo
Placebo + Standard of Care (SOC)
干预措施: Placebo (Drug)
结局指标
主要结局
SLE Responder Index (SRI-4)
时间窗: Week 52
Proportion of subjects achieving an SLE Responder Index (SRI-4) response
次要结局
- SLE Responder Index (SRI-4)(Week 24)
- SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods(Week 52)
- BILAG-based Combined Lupus Assessment (BICLA) Response(Week 52)
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Week 52)
- Achieve and sustain a low dose of corticosteriods(Week 52)
- Time to Flare(Up to Week 52)