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Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis
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
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 * BSA ≥10% * 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 Exclusion Criteria: * 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
About the study
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
What is being tested
- ENV-294 (drug)
- Placebo (drug)
Sponsor: Enveda Therapeutics · Participants: 105 · Started: Dec 22, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT07298395
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.