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 Therapeutics17 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年12月22日最近更新:
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Enveda Therapeutics
- 入组人数
- 64
- 试验地点
- 17
- 主要终点
- To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
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 Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study.
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 ENV-294
- 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 had either: (1) a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months, as determined by the study doctor, or (2) a poor response to treatments administered by mouth within the past 12 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, including but not limited to: cardiovascular, neurological, kidney, liver, gastrointestinal, cancer, autoimmune disease, HIV, hepatitis B, hepatitis C, or psychiatric disorders.
- •Any illness that could impact participant safety, clinically significant depression (as determined by the investigator), or active bacterial, fungal, or viral infections.
- •Have an ongoing skin condition or large tattoos that would interfere with the clinical assessment, evaluation of atopic dermatitis, or treatment response.
- •Have an ongoing clinically significant skin infection or receiving treatment for infection that may interfere with assessment of atopic dermatitis.
- •Have clinically significant abnormal clinical laboratory assessments at the first or second study visit as determined by the Investigator.
研究组 & 干预措施
Placebo Arm
Placebo Comparator
A placebo (matching the appearance of the experimental drug) will be administered to those participants who are 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 (Day 85)
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 (Day 85))
- Observed value, change from baseline, and percent change from baseline in heart rate (beats per minute) as a measure of safety and tolerability.(Baseline throug the treatment period and the end of study at approximately week 16.)
- To evaluate pharmacokinetics (PK) using limited blood samples during the 12-week treatment period.(Baseline through Week 12 (Day 85))
- Observed values, change from baseline, and percent change from baseline in heart rate (beats per minute) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and the end of study at approximately week 16.)
- Observed value, change from baseline, and percent change from baseline in systolic blood pressure (mmHg) as a measure of safety and tolerability.(Baseline through the end of the treatment period and the end of the study at approximately week16.)
- To assess the efficacy of ENV-294 in participants with AD over a 12- Week treatment period(Baseline through Week 12)
- Observed value, change from baseline, and percent change from baseline in diastolic blood pressure (mmHg) as a measure of safety and tolerability.(Baseline through the end of the treatment period at approximately week 16.)
- Observed value, change from baseline, and percent change from baseline in respiratory rate (breaths per minute) as a measure of safety and tolerability.(Baseline through the treatment priod and the end of the study at approximately week 16)
- Observed values, change from baseline, and percent change from baseline in QRS duration (milliseconds) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and end of study (approximately Week 16).)
- Observed values, change from baseline, and percent change from baseline in RR interval (milliseconds) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and end of study (approximately Week 16).)
- Observed values, change from baseline, and percent change from baseline in PR interval (milliseconds) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and end of study (approximately Week 16).)
- Observed values, change from baseline, and percent change from baseline in QTc Bazett (milliseconds) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and end of study (approximately Week 16).)
- Observed values, change from baseline, and percent change from baseline in QT interval (milliseconds) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and end of study (approximately Week 16).)
- Observed values, change from baseline, and percent change from baseline in QTc Fridericia (milliseconds) as a measure of safety and tolerability of ENV-294.(Baseline through treatment and end of study (approximately Week 16).)
- To evaluate how well ENV-294 works in participants with atopic dermatitis during 12 weeks of treatment.(Baseline through Week 12)
- To evaluate how well ENV-294 works in participants with atopic dermatitis during 12 weeks of treatment.(Baseline to Week 12 (Day 85))
研究者
研究点 (17)
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