Recruiting

Phase 2

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

Sponsor:

Enveda Therapeutics

Code:

NCT07298395

Conditions

Atopic Dermatitis (AD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ENV-294

Placebo

Study Details

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

Conditions

Atopic Dermatitis (AD)

Study ID

NCT07298395

Start date

Dec 22, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ENV-294 Treatment Arm

ENV-294 will be administered to those participants randomized to the treatment arm.

placebo comparator: Placebo Arm

A placebo will be administered to those participants randomized to the placebo arm.

Interventions

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

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.

Primary outcome measure

To evaluate the efficacy of ENV-294 compared to placebo on severity and extent of atopic dermatitis (AD) [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Clinical Operations

env-294.clinicaltrials@enveda.com

Locations

Enveda Investigative Site

Recruiting

Birmingham, Alabama, United States, 35244

Enveda Investigative Site

Recruiting

Hot Springs, Arkansas, United States, 71913

Enveda Investigative Site

Recruiting

Beverly Hills, California, United States, 90212

Enveda Investigative Site

Recruiting

Fremont, California, United States, 94538

Enveda Investigative Site

Recruiting

San Diego, California, United States, 92121

Enveda Investigative Site

Recruiting

San Diego, California, United States, 92123

Enveda Investigative Site

Recruiting

Santa Monica, California, United States, 90403

Enveda Investigative Site

Recruiting

West Hills, California, United States, 91307

Enveda Investigative Site

Recruiting

Fort Lauderdale, Florida, United States, 33308

Enveda Investigative Site

Recruiting

Miami, Florida, United States, 33175

Enveda Investigative Site

Recruiting

Miramar, Florida, United States, 33027

Enveda Investigative Site

Recruiting

Atlanta, Georgia, United States, 30327

Enveda Investigative Site

Recruiting

Chicago, Illinois, United States, 60657

Enveda Investigative Site

Recruiting

Clarksville, Indiana, United States, 47129

Enveda Investigative Site

Recruiting

New Albany, Indiana, United States, 47150

Enveda Investigative Site

Recruiting

West Lafayette, Indiana, United States, 47906

Enveda Investigative Site

Recruiting

Louisville, Kentucky, United States, 40217

Enveda Investigative Site

Recruiting

Louisville, Kentucky, United States, 40241

Enveda Investigative Site

Recruiting

Auburn Hills, Michigan, United States, 48326

Enveda Investigative Site

Recruiting

Bay City, Michigan, United States, 48706

Enveda Investigative Site

Recruiting

Clinton Township, Michigan, United States, 48038

Enveda Investigative Site

Recruiting

Warren, Michigan, United States, 48088

Enveda Investigative Site

Recruiting

Las Vegas, Nevada, United States, 89145

Enveda Investigative Site

Recruiting

New York, New York, United States, 10029

Enveda Investigative Site

Recruiting

Wilmington, North Carolina, United States, 28405

Enveda Investigative Site

Recruiting

Canton, Ohio, United States, 44718

Enveda Investigative Site

Recruiting

Mayfield Heights, Ohio, United States, 44124

Enveda Investigative Site

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Enveda Investigative Site

Recruiting

Arlington, Texas, United States, 76011

Enveda Investigative Site

Recruiting

Houston, Texas, United States, 77004

Enveda Investigative Site

Recruiting

San Antonio, Texas, United States, 78218

Enveda Investigative Site

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Enveda Therapeutics

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Enveda Therapeutics on 2026-07-29.