NCT01162681已完成2 期
A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 547
- 试验地点
- 74
- 主要终点
- SLE response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active 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
- •Diagnosis of SLE by American College of Rheumatology guidelines.
- •On stable SLE treatment
- •Active SLE disease
- •Serologically active
- •18 years of age or older
- •Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
排除标准
- •Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
- •Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
- •Liver disease.
- •Anemia, neutropenia, or thrombocytopenia.
- •Malignancy within past 5 years
- •Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
- •History of active tuberculosis or a history of tuberculosis infection.
- •Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
- •Prior administration of any B cell depleting therapy in the past 18 months.
- •Pregnant or nursing
- •History of congenital immunodeficiency
研究组 & 干预措施
A-623 high dose weekly
Experimental
干预措施: A-623 (Drug)
A-623 low dose weekly
Experimental
干预措施: A-623 (Drug)
A-623 high dose every 4 weeks
Experimental
干预措施: A-623 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Comparator (Other)
结局指标
主要结局
SLE response
时间窗: Various timepoints through Week 52
The % of subjects with SLE response compared with baseline at the time of assessment
次要结局
- Reduction in prednisone dose(Various timepoints through Week 52)
- Time to first flare(Various timepoints through Week 52)
- SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9(Various timepoints through Week 52)
- B cell reduction(Various timepoints through Week 52)
- FACIT-fatigue score(Various timepoints through Week 52)
- Change in IgG, IgM,C3 and C4(Various timepoints through Week 52)
- Flare rates(Various timepoints through Week 52)
研究者
研究点 (74)
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