NCT02074020撤回3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Proportion of responders to the SRI-8 composite responder index
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
- •Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
- •Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
- •Subjects with stable nephritis may be enrolled
- •18 years of age or older
排除标准
- •Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes
- •Malignancy within past 5 years
- •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
- •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
- •Pregnant or nursing
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Blisibimod
Experimental
干预措施: Blisibimod (Drug)
结局指标
主要结局
Proportion of responders to the SRI-8 composite responder index
时间窗: 52 Weeks
次要结局
- Time to first severe SLE flare(Baseline through 52 weeks)
- Change in the number of actively tender or swollen joints and in mucocutaneous disease activity(52 Weeks)
- Change in proteinuria from baseline(Week 52)
- Proportion of subjects able to reduce oral steroid dose(Baseline through 52 weeks)
- Proportion of subjects with improved patient-reported outcomes(Week 52)
- Time to treatment failure(Through week 52)
- Change from baseline in B cell subsets, anti-dsDNA, C3, C4(Through week 52)
- Safety profile (AEs, vital signs, labs, physical exams)(Through week 52)
研究者
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