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 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

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.