A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 865
- 试验地点
- 92
- 主要终点
- SLE Responder Index (SRI) Response Rate at Week 52
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
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
- •Clinical diagnosis of SLE by ACR criteria.
- •Active SLE disease.
- •Autoantibody-positive.
- •On stable SLE treatment regimen.
排除标准
- •Pregnant or nursing
- •Have received treatment with any B cell targeted therapy.
- •Have received treatment with a biological investigational agent in the past year.
- •Have received IV cyclophosphamide within 180 days of Day
- •Have severe lupus kidney disease.
- •Have active central nervous system (CNS) lupus.
- •Have required management of acute or chronic infections within the past 60 days.
- •Have current drug or alcohol abuse or dependence.
- •Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Belimumab 1 mg/kg
Belimumab 1 mg/kg
干预措施: Belimumab 1 mg/kg (Drug)
Belimumab 10 mg/kg
Belimumab 10 mg/kg
干预措施: Belimumab 10 mg/kg (Drug)
结局指标
主要结局
SLE Responder Index (SRI) Response Rate at Week 52
时间窗: Baseline, 52 weeks
Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).
次要结局
- Mean Change in Physician's Global Assessment (PGA) at Wk 24.(Baseline, 24 weeks)
- Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52(Baseline, Weeks 40 through 52)
- Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.(Baseline, 52 weeks)
- Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.(Baseline, 24 weeks)