NCT07298395From ClinicalTrials.govRecruiting

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

Atopic Dermatitis (AD)

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Enveda Therapeutics
Enrolment target: 105
Started: 22 December 2025
Main results due: December 2026
Study sites: 32
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(32)

Enveda Investigative Site
Birmingham, Alabama, United States
Recruiting
Enveda Investigative Site
Hot Springs, Arkansas, United States
Recruiting
Enveda Investigative Site
Beverly Hills, California, United States
Recruiting
Enveda Investigative Site
Fremont, California, United States
Recruiting
Enveda Investigative Site
San Diego, California, United States
Recruiting
Enveda Investigative Site
San Diego, California, United States
Recruiting
Enveda Investigative Site
Santa Monica, California, United States
Recruiting
Enveda Investigative Site
West Hills, California, United States
Recruiting
Enveda Investigative Site
Fort Lauderdale, Florida, United States
Recruiting
Enveda Investigative Site
Miami, Florida, United States
Recruiting
Enveda Investigative Site
Miramar, Florida, United States
Recruiting
Enveda Investigative Site
Atlanta, Georgia, United States
Recruiting
Enveda Investigative Site
Chicago, Illinois, United States
Recruiting
Enveda Investigative Site
Clarksville, Indiana, United States
Recruiting
Enveda Investigative Site
New Albany, Indiana, United States
Recruiting
Enveda Investigative Site
West Lafayette, Indiana, United States
Recruiting
Enveda Investigative Site
Louisville, Kentucky, United States
Recruiting
Enveda Investigative Site
Louisville, Kentucky, United States
Recruiting
Enveda Investigative Site
Auburn Hills, Michigan, United States
Recruiting
Enveda Investigative Site
Bay City, Michigan, United States
Recruiting
Enveda Investigative Site
Clinton Township, Michigan, United States
Recruiting
Enveda Investigative Site
Warren, Michigan, United States
Recruiting
Enveda Investigative Site
Las Vegas, Nevada, United States
Recruiting
Enveda Investigative Site
New York, New York, United States
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Enveda Investigative Site
Wilmington, North Carolina, United States
Recruiting
Enveda Investigative Site
Canton, Ohio, United States
Recruiting
Enveda Investigative Site
Mayfield Heights, Ohio, United States
Recruiting
Enveda Investigative Site
Camp Hill, Pennsylvania, United States
Recruiting
Enveda Investigative Site
Arlington, Texas, United States
Recruiting
Enveda Investigative Site
Houston, Texas, United States
Recruiting
Enveda Investigative Site
San Antonio, Texas, United States
Recruiting
Enveda Investigative Site
Norfolk, Virginia, United States
Recruiting

Showing 32 of 32 sites. 32 of the 32 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07298395. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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