A Randomized, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Eczema Area and Severity Index(EASI)
研究概览
简要总结
The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood and skin will be evaluated. Comparisons of the effect of QGE31 will be made with placebo and also cyclosporine, a treatment already established as being effective in atopic dermatitis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 QGE031
QGE031 will be administered as a subcutaneous dose q2 weeks
干预措施: QGE031 (Drug)
Group 2 Placebo
A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks
干预措施: Placebo (Drug)
Group 3 Cyclosporine A
Cyclosporine A will be administered (as per label) for atopic dermatitis.
干预措施: Cyclosporine A (Drug)
结局指标
主要结局
Change in Eczema Area and Severity Index(EASI)
时间窗: baseline, 12 weeks
Efficacy response will be assessed using EASI.
次要结局
- Number of participants with adverse events(24 weeks)
- Change in Investigator Global Assessment (IGA) for atopic dermatitis(6 weeks, 12 weeks)
- QGE031 plasma concentrations(24 weeks)