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

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

Individual participant data (IPD) will not be shared. The data include sensitive health information that cannot be fully de-identified under current privacy standards, and the sponsor does not plan to make IPD available outside the study team. Summary results and aggregate data will be shared publicly as required by regulation.