A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 61
- 主要终点
- Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
详细描述
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo plus SOC
干预措施: Placebo (Drug)
Belimumab 1 mg/kg plus SOC
干预措施: Belimumab 1 mg/kg (Drug)
Belimumab 4 mg/kg plus SOC
干预措施: Belimumab 4 mg/kg (Drug)
Belimumab 10 mg/kg plus SOC
干预措施: Belimumab 10 mg/kg (Drug)
结局指标
主要结局
Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
时间窗: Baseline, 24 weeks
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
时间窗: 0 to 52 weeks
The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
次要结局
- Percentage Change From Baseline in SELENA SLEDAI Score at Week 52(Baseline, 52 weeks)
- Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52(Baseline and every 4 to 8 weeks through Week 52)
- Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52(Baseline, 52 weeks)
- Area Under the Curve (AUC) of BILAG Score at Week 52(Baseline and every 4 to 8 weeks through Week 52)
- Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks(0 to 52 weeks)
- Percentage of Patients With a Reduction in Prednisone Dose(Baseline, weeks 40 to 52)