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NCT07298395PHASE2Recruiting

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

Enveda Therapeutics

Start Date

12/22/2025

Completion Date

12/1/2026

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

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

ENV-294

DRUG

Placebo

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Conditions

Atopic Dermatitis (AD)

Locations

Enveda Investigative Site

Birmingham, Alabama 35244

United States

Enveda Investigative Site

Hot Springs, Arkansas 71913

United States

Enveda Investigative Site

Beverly Hills, California 90212

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

Santa Monica, California 90403

United States

Enveda Investigative Site

West Hills, California 91307

United States

Enveda Investigative Site

Fort Lauderdale, Florida 33308

United States

Enveda Investigative Site

Miami, Florida 33175

United States

Enveda Investigative Site

Miramar, Florida 33027

United States

Enveda Investigative Site

Atlanta, Georgia 30327

United States

Enveda Investigative Site

Chicago, Illinois 60657

United States

Enveda Investigative Site

Clarksville, Indiana 47129

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

Louisville, Kentucky 40241

United States

Enveda Investigative Site

Auburn Hills, Michigan 48326

United States

Enveda Investigative Site

Bay City, Michigan 48706

United States

Enveda Investigative Site

Clinton Township, Michigan 48038

United States

Enveda Investigative Site

Warren, Michigan 48088

United States

Enveda Investigative Site

Las Vegas, Nevada 89145

United States

Enveda Investigative Site

New York, New York 10029

United States

Enveda Investigative Site

Wilmington, North Carolina 28405

United States

Enveda Investigative Site

Canton, Ohio 44718

United States

Enveda Investigative Site

Mayfield Heights, Ohio 44124

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