A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 306
- 试验地点
- 137
- 主要终点
- Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
研究概览
简要总结
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible male and female subjects, aged 18 years or older
- •Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit
- •At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit)
- •Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
- •Other protocol defined inclusion criteria could apply
排除标准
- •Subjects have demyelinating disorder
- •Severe central nervous system SLE
- •Use of cyclophosphamide within 3 months of the screening visit
- •Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Atacicept 75 mg
干预措施: Atacicept 75 milligram (mg) (Drug)
Atacicept 150 mg
干预措施: Atacicept 150 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
时间窗: Week 24
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
时间窗: Week 24
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
次要结局
- Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24(Screening and Week 24)
- Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity(Week 24)
- Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24(Week 24)
- Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks))
- Time From Randomization to First SRI Response During Treatment Period(Baseline up to 24 Weeks)
- Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24(Week 24)
- Change From Week 0 (Day 1) in SF-36 Components at Week 24(Week 0 (Day 1) and Week 24)