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

ACTIVE_NOT_RECRUITINGPHASE1

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

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Escalation, and Food Effect Study of ENV-294 in Healthy Adult Participants With a Phase 1b Extension in Adults With Moderate-To-Severe Atopic Dermatitis

NCT07336940•Enveda Therapeutics

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms. The main questions it will answer are: * Is ENV-294 safe and well tolerated in adults with moderate to severe atopic dermatitis? * Is there an impact on the severity of atopic dermatitis symptoms when participants take 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 once every day for 28 days * Visit the clinic weekly for 4 weeks for checkups and tests * Keep a diary of their symptoms and when they took their study drug ENV-294

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be male or female participants who are 18 to 75 years of age
•Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to the first study visit
•Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for used atopic dermatitis
•Have moderate-to-severe atopic dermatitis, at the first two study visits
•Use an emollient (except those containing urea) daily for at least 1 week prior to the first study visit and throughout the study

Exclusion Criteria

•Have any uncontrolled current or recurrent concomitant illness (eg, hepatitis B surface antigen, hepatitis C virus, or other condition) that could affect the study drug, clinical or laboratory assessments, or could impact participant safety.
•Are using any medication (prescription or over-the-counter) that may interfere with the study product safety evaluations within 14-days prior to the second study visit.
•Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response.

Locations (5)

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Skin Sciences, PLLC

Louisville, Kentucky, United States

J & S Studies

College Station, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Virginia Dermatology & Skin Cancer Center

Norfolk, Virginia, United States

Key Dates

Start Date

September 10, 2025

Primary Completion Date

February 1, 2026

Completion Date

March 1, 2026

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

ENV-294 Capsule

DRUG

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

NCT07298395

Atopic Dermatitis (AD)

View study

RECRUITINGPHASE1

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

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: January 13, 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 Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis

Inclusion Criteria

Exclusion Criteria

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

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