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
1 other identifier
interventional
60
1 country
17
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedFirst Posted
Study publicly available on registry
December 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 23, 2026
April 1, 2026
11 months
December 10, 2025
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
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 Outcomes (6)
Incidence and Severity of Adverse Events
Baseline to Week 12
EASI-75 Response
Baseline to Week 12
vIGA Response
Baseline to Week 12
Patient-Reported Outcomes
Baseline to Week 12
Patient-Reported Outcomes
Baseline to Week 12
- +1 more secondary outcomes
Study Arms (2)
ENV-294 Treatment Arm
EXPERIMENTALENV-294 will be administered to those participants randomized to the treatment arm.
Placebo Arm
PLACEBO COMPARATORA placebo will be administered to those participants randomized to the placebo arm.
Interventions
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.
ENV-294 is an orally administered investigational drug supplied as tablets. Participants receive ENV-294 once daily by mouth for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Enveda Investigative Site
Birmingham, Alabama, 35244, United States
Enveda Investigative Site
Hot Springs, Arkansas, 71913, United States
Enveda Investigative Site
Fremont, California, 94538, United States
Enveda Investigative Site
San Diego, California, 92121, United States
Enveda Investigative Site
San Diego, California, 92123, United States
Enveda Investigative Site
New Albany, Indiana, 47150, United States
Enveda Investigative Site
West Lafayette, Indiana, 47906, United States
Enveda Investigative Site
Louisville, Kentucky, 40217, United States
Enveda Investigative Site
Auburn Hills, Michigan, 48326, United States
Enveda Investigative Site
Clinton Township, Michigan, 48038, United States
Enveda Investigative Site
Las Vegas, Nevada, 89145, United States
Enveda Investigative Site
Canton, Ohio, 44718, United States
Enveda Investigative Site
Camp Hill, Pennsylvania, 17011, United States
Enveda Investigative Site
Arlington, Texas, 76011, United States
Enveda Investigative Site
Houston, Texas, 77004, United States
Enveda Investigative Site
San Antonio, Texas, 78218, United States
Enveda Investigative Site
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gurpreet Ahluwalia, PhD
Enveda Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2025
First Posted
December 23, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.