Home › Trials › NCT07298395

ENV-294 for 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

Phase 2 Interventional Enveda Therapeutics · NCT07298395

This trial tests whether taking ENV-294 daily for 12 weeks reduces rash and itch in adults with moderate-to-severe atopic dermatitis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEnveda Therapeutics Industry-sponsored
Locations20 sites (Birmingham, Alabama and 19 other locations)
Trial IDNCT07298395 on ClinicalTrials.gov

What this trial studies

Adults with chronic moderate-to-severe atopic dermatitis will take ENV-294 or a matching placebo once daily for 12 weeks and return for clinic visits every 2 to 4 weeks with a final visit around week 16. The study will measure skin severity and affected area using clinician scales (vIGA, EASI, BSA) and patient-reported itch (PP-NRS), while monitoring adverse events and laboratory tests for safety. Participants will keep daily symptom and dosing diaries to support adherence and outcome collection. Eligibility requires at least 12 months of AD history and prior inadequate response or intolerance to topical therapies.

Who should consider this trial

Good fit: Adults with chronic moderate-to-severe atopic dermatitis (vIGA 3–4, EASI ≥16, BSA ≥10%, PP-NRS ≥4) who had inadequate response or intolerance to topical treatments and can attend regular clinic visits are the ideal candidates.

Not a fit: People with mild AD, active skin infections, significant laboratory abnormalities, or other medical conditions that could interfere with assessments are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, ENV-294 could reduce skin inflammation, decrease the area of affected skin, and relieve itch for adults with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other systemic agents, including biologics and JAK inhibitors, have improved outcomes in moderate-to-severe AD, but ENV-294 is an investigational agent with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic Dermatitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.