A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 11
- 主要终点
- Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
研究概览
简要总结
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
详细描述
This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.
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
- None
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 American College of Rheumatology (ACR) criteria
- •Active SLE disease
- •On stable SLE treatment regimen
排除标准
- •Pregnant or nursing
- •Have received treatment with an B cell targeted therapy
- •Have received treatment with a biologic investigational agent in the past year
- •Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
- •Have severe lupus kidney disease
- •Have active central nervous system (CNS) lupus
- •Have required management of acute or chronic infections with the past 60 days
- •Have current drug or alcohol abuse or dependence or within the past year
- •Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention
研究组 & 干预措施
Belimumab Q2WKS
Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
干预措施: Belimumab 100 mg SC (Drug)
Belimumab 3X/WK
Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
干预措施: Belimumab 100 mg SC (Drug)
结局指标
主要结局
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
时间窗: Baseline, 24 Weeks
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
时间窗: Up to 24 weeks
SEE ALSO ADVERSE EVENTS RESULTS SECTION
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24
时间窗: Baseline, 24 weeks
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
时间窗: Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
时间窗: Baseline, 24 weeks
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
时间窗: Baseline, 24 weeks
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
时间窗: Baseline, 24 Weeks
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
时间窗: Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
时间窗: Baseline, 24 Weeks
次要结局
- Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.(Baseline, 24 weeks)
- Absolute Change From Baseline in IgA at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in IgA at Week 24(Baseline, 24 weeks)
- Absolute Change From Baseline in IgG at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in IgG at Week 24(Baseline, 24 Weeks)
- Absolute Change From Baseline in IgM at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in IgM at Week 24(Baseline, 24 weeks)
- Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24(Baseline, 24 Weeks)
- Mean Percent Change From Baseline in PGA Score at Week 24.(Baseline, 24 weeks)
- Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24(Baseline, 24 Weeks)
- Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24(Baseline, 24 weeks)
- Absolute Change From Baseline in Complement C3 at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in Compliment C3 at Week 24(Baseline, 24 Weeks)
- Absolute Change From Baseline in Complement C4 at Week 24(Baseline, 24 weeks)
- Median Percent Change From Baseline in Complement C4 at Week 24(Baseline, 24 Weeks)
- Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in Anti-dsDNA at Week 24(Baseline, 24 weeks)
- Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in HDL at Week 24(Baseline, 24 week)
- Absolute Change From Baseline in Total Cholesterol at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in Total Cholesterol at Week 24(Baseline, 24 Weeks)
- Median Percent Change From Baseline in Triglycerides at Week 24(Baseline, 24 weeks)
- Absolute Change From Baseline in Triglycerides at Week 24(Baseline, 24 Weeks)