NCT02711813终止2 期
Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Theramab LLC
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number and proportion of treatment responders per SLE Responder Index (SRI)
研究概览
简要总结
The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
- •Active SLE (SLE Disease Activity Index ≥ 6)
- •Skin or joint SLE manifestations
排除标准
- •Lupus-nephritis and/or central nervous system affection (neuro-lupus)
- •Prohibited treatment
- •Pregnant or nursing women
- •Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo to TAB08
干预措施: Placebo (Other)
TAB08 Dose 1
Experimental
干预措施: TAB08 (Drug)
TAB08 Dose 2
Experimental
干预措施: TAB08 (Drug)
结局指标
主要结局
Number and proportion of treatment responders per SLE Responder Index (SRI)
时间窗: 24 weeks
Adverse Events
时间窗: 24 weeks
次要结局
- Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)(24 weeks)
- Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)(24 weeks)
研究者
研究点 (1)
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