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Study of ENV-294 for Moderate-to-Severe Atopic Dermatitis

This study is testing a new oral medication called ENV-294 for adults with moderate-to-severe atopic dermatitis (eczema). Researchers want to see if ENV-294 can reduce the severity and area of your eczema, and what side effects you might experience. You would take ENV-294 or a placebo (an inactive pill) once daily for 12 weeks. To be eligible, you need to be between 18 and 75 years old, have chronic eczema diagnosed at least a year ago, and meet specific criteria for moderate-to-severe eczema, including a history of poor response or intolerance to topical treatments. The main goal is to compare how well ENV-294 works against the placebo in improving your eczema.

Study design
This is an interventional study comparing ENV-294 to a placebo in approximately 60 adult participants. The phase of the study is not specified.
What's involved
You would take ENV-294 or a placebo daily for 12 weeks, visit the clinic every 2 to 4 weeks for checkups, keep a symptom diary, and have a final visit around week 16.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a final study visit at approximately week 16, which is about 4 weeks after the 12-week treatment period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07298395

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Enveda Therapeutics
~60 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:ENV-294Placebo

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)
Measured over Baseline to Week 12

Conditions

Atopic Dermatitis (AD)

Explore related trials

Atopic Dermatitis

Where it's being run

32 sites across 16 states
California6
Michigan4
Florida3
Indiana3
Texas3
Kentucky2
Ohio2
Alabama1

Study leadership

  • Gurpreet Ahluwalia, PhD · STUDY_DIRECTOR · Enveda Therapeutics, Inc.

Who to contact

Clinical Operations
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD)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.