NCT07643766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 Therapeutics10 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年6月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
研究概览
简要总结
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
- •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.
排除标准
- •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.
研究组 & 干预措施
ENV-294 Treatment Arm (Dose 3)
Experimental
干预措施: ENV-294 (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Other)
ENV-294 Treatment Arm (Dose 2)
Experimental
干预措施: ENV-294 (Drug)
ENV-294 Treatment Arm (Dose 1)
Experimental
干预措施: ENV-294 (Drug)
研究者
研究点 (10)
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