NCT07150845进行中（未招募）2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults With Atopic Dermatitis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 52
- 主要终点
- Percentage change in Eczema Area and Severity Index (EASI) from Baseline
研究概览
简要总结
This study will evaluate the efficacy and safety of different doses of EVO756 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
- 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
- •Chronic AD that has been present for ≥6 months
- •Validated-Investigator's Global Assessment score of ≥3
- •EASI of ≥16
- •BSA of AD involvement of ≥10%
排除标准
- •Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening
- •Use of certain medications
- •Presence of skin comorbidities or other condition(s) that may interfere with study assessments
- •Significant AD flare, in the opinion of the Investigator, within 4 weeks prior to study entry
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo control
干预措施: Placebo control (Drug)
Dose 1
Experimental
Orally administered EVO756, Dose 1
干预措施: EVO756 (Drug)
Dose 2
Experimental
Orally administered EVO756, Dose 2
干预措施: EVO756 (Drug)
Dose 3
Experimental
Orally administered EVO756, Dose 3
干预措施: EVO756 (Drug)
结局指标
主要结局
Percentage change in Eczema Area and Severity Index (EASI) from Baseline
时间窗: Week 12
次要结局
- Mean and absolute changes in validated Investigator Global Assessment (vIGA) score from Baseline(Weeks 2, 4, 8, and 12)
- Percentage change in EASI from Baseline(Weeks 2, 4, and 8)
- Mean changes in EASI from Baseline(Week 2, 4, 8, and 12)
- Proportion of subjects with EASI-50, EASI-75, and EASI-90 from Baseline(Weeks 2, 4, 8, and 12)
- Proportion of subjects achieving a vIGA score of 0,1 with at least a 2-point reduction from Baseline(Weeks 2, 4, 8, and 12)
- Mean and percentage change from Baseline in the pruritus-NRS score(Weeks 2, 4, 8, and 12)
- Proportion of subjects achieving a 4-pt reduction in the pruritus-NRS score from Baseline(Week 2, 4, 8, and 12)
- Mean and percentage changes from Baseline in Body Surface Area (BSA) of affected area(Weeks 2, 4, 8, and 12)
- Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE)(through Week 14)
研究者
研究点 (52)
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