NCT07298395招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Enveda Therapeutics32 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年12月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 32
- 主要终点
- To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis.
The main questions it will answer are:
- Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294
- What medical problems do participants have when taking ENV-294
Participants will:
- Take drug ENV-294 or a placebo once every day for 12 weeks
- Visit the clinic every 2 to 4 weeks for checkups and tests
- Keep a diary of their symptoms and when they took their study drug
- Return to the clinic for the final study visit at approximately week 16
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
- •Have moderate-to-severe AD at screening and baseline as defined by the following criteria:
- •A vIGA score of 3 (moderate) or 4 (severe)
- •EASI score of ≥16
- •PP-NRS score of ≥4
- •Have had either a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months
- •Use a bland moisturizer at least daily
排除标准
- •Current or recurrent medical conditions that could affect the study drug or study assessments
- •Any illness that could impact participant safety or active infections
- •Ongoing skin condition or large tattoos that would interfere with clinical assessment
- •Clinically significant skin infection requiring treatment
- •Clinically significant abnormal laboratory assessments at screening
研究组 & 干预措施
Placebo Arm
Placebo Comparator
A placebo will be administered to those participants randomized to the placebo arm.
干预措施: Placebo (Drug)
ENV-294 Treatment Arm
Experimental
ENV-294 will be administered to those participants randomized to the treatment arm.
干预措施: ENV-294 (Drug)
结局指标
主要结局
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
时间窗: Baseline to Week 12
The effectiveness of ENV-294 compared with placebo will be assessed by the percent change in Eczema Area and Severity Index (EASI) score from the start of the study (Baseline) to Week 12 (Day 85). The EASI score measures the extent and severity of atopic dermatitis, with higher scores indicating more severe disease.
次要结局
- Incidence and Severity of Adverse Events(Baseline to Week 12)
- EASI-75 Response(Baseline to Week 12)
- vIGA Response(Baseline to Week 12)
- Patient-Reported Outcomes(Baseline to Week 12)
- Pharmacokinetics of ENV-294(Baseline to Week 12)
研究者
研究点 (32)
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