Overview
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
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
