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Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07298395•Enveda Therapeutics

View on ClinicalTrials.gov

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 Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study. 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 ENV-294 * Return to the clinic for the final study visit at approximately week 16

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have chronic atopic dermatitis that was diagnosed at least 12 months prior to the first study visit
•Have had either: (1) a poor response or intolerance to topical treatments for atopic dermatitis (such as corticosteroids) within the past 6 months, as determined by the study doctor, or (2) a poor response to treatments administered by mouth within the past 12 months.
•Use a bland moisturizer at least daily

Exclusion Criteria

•Current or recurrent medical conditions that could affect the study drug or study assessments, including but not limited to: cardiovascular, neurological, kidney, liver, gastrointestinal, cancer, autoimmune disease, HIV, hepatitis B, hepatitis C, or psychiatric disorders.
•Any illness that could impact participant safety, clinically significant depression (as determined by the investigator), or active bacterial, fungal, or viral infections.
•Have an ongoing skin condition or large tattoos that would interfere with the clinical assessment, evaluation of atopic dermatitis, or treatment response.
•Have an ongoing clinically significant skin infection or receiving treatment for infection that may interfere with assessment of atopic dermatitis.
•Have clinically significant abnormal clinical laboratory assessments at the first or second study visit as determined by the Investigator.

Locations (12)

Cahaba & Skin Health Center

Birmingham, Alabama, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Center for Dermatology Clinical Research

Fremont, California, United States

TCR Medical Corporation

San Diego, California, United States

Southern Indiana Clinical Trials

New Albany, Indiana, United States

Options Research Group

West Lafayette, Indiana, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

Best Skin Research

Camp Hill, Pennsylvania, United States

Arlington Research Center

Arlington, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Key Dates

Start Date

December 22, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

ENV-294

DRUG

Placebo

DRUG

Contacts

Clinical Operations

CONTACT

env-294.clinicaltrials@enveda.com

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

NCT07235384

Atopic Dermatitis (AD)

View study

RECRUITINGNA

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

NCT07259343

Atopic Dermatitis (AD)

View study

RECRUITINGPHASE2/PHASE3

Herbal Ointment in Treating Atopic Dermatitis Topically

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Herbal Ointment in Treating Atopic Dermatitis Topically

Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis

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