NCT06723405已完成2 期
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults With Atopic Dermatitis
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
- 71
- 试验地点
- 12
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.
详细描述
This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe 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
- Triple (Participant, 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
- •Males or non-pregnant, non-lactating females, age 18 years or older
- •Chronic atopic dermatitis for at least 6 months
- •BSA of AD involvement of at least 10%
- •EASI score of at least 16.
排除标准
- •Significant AD flare with 4 weeks
- •Use of biologic therapy within 12 weeks
- •Regular use of tanning booth within 4 weeks
- •Skin condition that could interfere with study assessments
研究组 & 干预措施
Intravenous EVO301
Experimental
干预措施: EVO301 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: 12 weeks
EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.
次要结局
- Investigator Global Assessment (IGA)(12 weeks)
- Body Surface Area (BSA)(12 weeks)
- Pruritus-NRS(12 weeks)
研究者
研究点 (12)
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