Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

June 2, 2026 updated by: Enveda Therapeutics

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Enveda Investigative Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • Enveda Investigative Site
    • California
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Enveda Investigative Site
      • Fremont, California, United States, 94538
        • Recruiting
        • Enveda Investigative Site
      • San Diego, California, United States, 92121
        • Recruiting
        • Enveda Investigative Site
      • San Diego, California, United States, 92123
        • Recruiting
        • Enveda Investigative Site
      • West Hills, California, United States, 91307
        • Recruiting
        • Enveda Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Recruiting
        • Enveda Investigative Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Enveda Investigative Site
      • West Lafayette, Indiana, United States, 47906
        • Recruiting
        • Enveda Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Recruiting
        • Enveda Investigative Site
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Enveda Investigative Site
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Enveda Investigative Site
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Enveda Investigative Site
      • Warren, Michigan, United States, 48088
        • Recruiting
        • Enveda Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Recruiting
        • Enveda Investigative Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Enveda Investigative Site
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Enveda Investigative Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • Enveda Investigative Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Recruiting
        • Enveda Investigative Site
      • Houston, Texas, United States, 77004
        • Recruiting
        • Enveda Investigative Site
      • San Antonio, Texas, United States, 78218
        • Recruiting
        • Enveda Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Enveda Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENV-294 Treatment Arm
ENV-294 will be administered to those participants randomized to the treatment arm.
Drug: ENV-294
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Placebo Comparator: Placebo Arm
A placebo will be administered to those participants randomized to the placebo arm.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
Time Frame: Baseline to Week 12
The effectiveness of ENV-294 compared with placebo will be assessed by the percent change in Eczema Area and Severity Index (EASI) score from the start of the study (Baseline) to Week 12 (Day 85). The EASI score measures the extent and severity of atopic dermatitis, with higher scores indicating more severe disease.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Adverse Events
Time Frame: Baseline to Week 12
Number and seriousness of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
Baseline to Week 12
EASI-75 Response
Time Frame: Baseline to Week 12
Percentage of participants with at least 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score.
Baseline to Week 12
vIGA Response
Time Frame: Baseline to Week 12
Proportion of participants who achieve a ≥2-point reduction from Baseline in validated Global Investigator Assessment (vIGA) score and a score of 0 or 1.
Baseline to Week 12
Patient-Reported Outcomes
Time Frame: Baseline to Week 12
Change and percent change in Peak Pruritus Numerical Rating Scale (PP-NRS).
Baseline to Week 12
Patient-Reported Outcomes
Time Frame: Baseline to Week 12
Change and percent change in Patient Oriented Eczema Measure (POEM).
Baseline to Week 12
Pharmacokinetics of ENV-294
Time Frame: Baseline to Week 12
Observed concentration values of ENV-294 at the times blood samples are collected.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enveda Therapeutics

Investigators

  • Study Director: Gurpreet Ahluwalia, PhD, Enveda Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENV-294-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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