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

NCT ID: NCT07336940

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2026-03-31

Brief 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

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label with once per day dosing

Group Type: EXPERIMENTAL

ENV-294 Capsule

Intervention Type: DRUG

ENV-294 formulated as 200mg capsules for oral administration will be used for this study.

Interventions

ENV-294 Capsule

ENV-294 formulated as 200mg capsules for oral administration will be used for this study.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enveda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

ENV-294-101

Identifier Type: -

Identifier Source: org_study_id