NCT00657007已完成1 期
A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 35
- 主要终点
- To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
研究概览
简要总结
The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with 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
- •Clinical diagnosis of SLE by ACR criteria
- •Stable SLE disease activity
- •On stable SLE treatment regimen
- •History of measurable autoantibodies
排除标准
- •Pregnant or nursing
- •Received a non-FDA approved investigational agent within last 28 days
- •Received cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 6 months
- •Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 6 months
- •Active central nervous system (CNS) lupus requiring medical intervention within last 6 months
- •History of renal transplant
- •History of clinical evidence of an active significant acute or chronic diseases
- •Have required management or hospitalization of any infection within last 4 weeks.
- •History of hypogammaglobulinemia or IgA deficiency
- •Have current drug or alcohol addiction
- •History of or test positive at screening for HIV, Hepatitis B or Hepatitis C
结局指标
主要结局
To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
时间窗: Days 0-105
次要结局
- To evaluate the effect of belimumab on clinical disease activity, total serum IgG (and IgM, IgA, IgE) and concentrations of peripheral mature B lymphocytes and plasmacytoid cells, and markers of SLE disease activity, including autoantibodies.(Days 0-105)
研究者
研究点 (35)
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