2026-526184-38-00招募中2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants with Moderate-to-Severe Atopic Dermatitis
Enveda Therapeutics Inc.17 个研究点 分布在 3 个国家目标入组 45 人开始时间: 2026年9月28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
- 45
- 试验地点
- 17
- 主要终点
- Percent change from Baseline inEczema Area and Severity Index (EASI) score at Week 12 (Day 85).
研究概览
简要总结
To evaluate the efficacy of ENV-294 doses compared with placebo on severity and extent of atopic dermatitis (AD).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age at the time of signing the ICF.
- •Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening and meets Hanifin and Rajka criteria (Hanifin et al, 1980) for AD and had no clinically significant flares for at least 4 weeks before Screening as assessed by the Investigator.
- •Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD as determined by the Investigator and/or inadequate response to a systemic therapy within 12 months before Screening.
- •Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria: a. A vIGA-AD score of 3 (moderate) or 4 (severe) b. EASI score of ≥16 c. Body surface area involvement of ≥10% (excluding scalp and groin area)
- •Have PP-NRS score ≥4 at Screening and Baseline (note: the Baseline score refers to a weekly average of daily assessments and the participants must complete at least 4 of the 7 daily assessments in the Week prior to Day 1)
- •Use a bland emollient without ingredients that could potentially impact clinical scores (ie, urea) daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.
排除标准
- •Have any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of study results. In addition, they will be excluded if they are positive for human immunodeficiency virus [HIV], hepatitis B surface antigen [HBsAg], or hepatitis C virus [HCV].
- •Have a history of suicidal ideation with actual intent and a specific plan within the past year, as indicated by a 'Yes' response to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS); or have answered 'Yes' to any suicidal behavior item on the C-SSRS within the past 5 years.
- •Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of study results.
- •Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response, as determined by the Investigator.
- •Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD, as determined by the Investigator.
研究组 & 干预措施
ENV-294-Placebo, NA, tablet
Placebo
干预措施: ENV-294-Placebo, NA, tablet (Drug)
ENV-294, ENV-294
Test
干预措施: ENV-294 (Drug)
结局指标
主要结局
Percent change from Baseline inEczema Area and Severity Index (EASI) score at Week 12 (Day 85).
Percent change from Baseline inEczema Area and Severity Index (EASI) score at Week 12 (Day 85).
次要结局
- 1. Incidence and severity of AEs, serious adverse events (SAEs), and AEs leading to treatment discontinuation 2. Observed value, change and percent change from Baseline in clinical laboratory values, and observed value and change from Baseline in electrocardiograms (ECGs), and vital signs
- 3. Proportion of participants who reach at least 75% reduction in EASI score from Baseline (EASI-75) at Week 12 4. Proportion of participants who achieve a ≥2-point reduction from Baseline in Validated Global Investigator Assessment Scale for Atopic Dermatitis (vIGA-AD) score and a score of 0 or 1 at Week 12
- 5. Change and percent change from Baseline in PatientOriented Eczema Measure (POEM) at Week 12 6. Peak Pruritus Numerical Rating Scale (PP-NRS) response status defined as achieving weekly mean decrease from Baseline of ≥4 points at Week 12
研究者
Gurpreet Ahluwalia, PhD
Scientific
Enveda Therapeutics Inc.
研究点 (17)
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