A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
2026年8月4日 更新者：Enveda Therapeutics
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
This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD).
The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks.
Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.
研究概览
研究类型
介入性
注册 (估计的)
200
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Clinical Operations
- 邮箱：env-294.clinicaltrials@enveda.com
学习地点
-
-
California
-
Encinitas、California、美国、92024
- 招聘中
- Enveda Investigative Site
-
Los Angeles、California、美国、90045
- 招聘中
- Enveda Investigative Site
-
Northridge、California、美国、91325
- 招聘中
- Enveda Investigative Site
-
-
Florida
-
Boca Raton、Florida、美国、33486
- 招聘中
- Enveda Investigative Site
-
-
Indiana
-
Indianapolis、Indiana、美国、46250
- 招聘中
- Enveda Investigative Site
-
Plainfield、Indiana、美国、46168
- 招聘中
- Enveda Investigative Site
-
-
Texas
-
Dallas、Texas、美国、75230
- 招聘中
- Enveda Investigative Site
-
San Antonio、Texas、美国、78213
- 招聘中
- Enveda Investigative Site
-
Sugar Land、Texas、美国、77479
- 招聘中
- Enveda Investigative Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
In order to participate in this study all participants must:
- 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.
- Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening 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 vIGA score of 3 (moderate) or 4 (severe)
- EASI score of ≥16
- Body surface area involvement of ≥10%
- Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
- Use a bland emollient 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.
- Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.
Exclusion Criteria:
Participants are excluded if they:
- 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.
- Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.
- 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.
- Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.
- Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂组
|
Matching oral tablet that does not contain active drug.
Administered once daily by mouth for 12 weeks under the same conditions as the investigational product.
|
|
实验性的：ENV-294 Treatment Arm (Dose 1)
|
ENV-294 是一种口服试验药物，以片剂形式提供。
参与者每日一次口服ENV-294，持续12周。
|
|
实验性的：ENV-294 Treatment Arm (Dose 2)
|
ENV-294 是一种口服试验药物，以片剂形式提供。
参与者每日一次口服ENV-294，持续12周。
|
|
实验性的：ENV-294 Treatment Arm (Dose 3)
|
ENV-294 是一种口服试验药物，以片剂形式提供。
参与者每日一次口服ENV-294，持续12周。
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percent change in Eczema Area and Severity Index (EASI) score
大体时间：Baseline to Week 12
|
Baseline to Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
vIGA应答
大体时间：基线至第12周
|
基线时研究者整体评估（vIGA）评分降低≥2分且评分达到0或1分的参与者比例
|
基线至第12周
|
|
Incidence of Treatment Emergent Adverse Events
大体时间：Baseline to Week 12 and Week 16
|
Baseline to Week 12 and Week 16
|
|
|
EASI-75 Response
大体时间：Baseline to Week 12
|
Proportion of participants with at least 75% reduction from Baseline in EASI score
|
Baseline to Week 12
|
|
Percent change in Scoring Atopic Dermatitis (SCORAD)
大体时间：Baseline to Week 12
|
Baseline to Week 12
|
|
|
Patient-Reported Outcomes
大体时间：Baseline to Week 12
|
Change in Patient Oriented Eczema Measure (POEM)
|
Baseline to Week 12
|
|
Patient-Reported Outcomes
大体时间：Baseline to Week 12
|
Peak Pruritus Numerical Rating Scale (PP-NRS): proportion of participants who achieve weekly mean decrease from Baseline of ≥4 points
|
Baseline to Week 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Gurpreet Ahluwalia, PhD、Enveda Therapeutics, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月29日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2026年6月7日
首先提交符合 QC 标准的
2026年6月7日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年8月6日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.