A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.
∙ In order to participate in this study all participants must:
• Be at least 18 years of age at the time of signing the ICF.
• Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.
• Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and/or inadequate response to a systemic therapy within 12 months before Screening.
• 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
⁃ Body surface area involvement of ≥10%
• Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.
• Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.
• Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.