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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

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