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

Completed · Phase 1

Conditions studied: Atopic Dermatitis (AD)

In brief

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

Key facts

Study ID

NCT07336940

Run by

Enveda Therapeutics

People needed

9

Starts

2025-09-10

Expected to finish

2026-01-13

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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