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

Condition studied

Atopic Dermatitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change from Baseline inEczema Area and Severity Index (EASI) score at Week 12 (Day 85).

Endpoint detail

1. Incidence and severity of AEs, serious adverse events (SAEs), and AEs leading to treatment discontinuation 2. Observed value, change and percent change from Baseline in clinical laboratory values, and observed value and change from Baseline in electrocardiograms (ECGs), and vital signs, 3. Proportion of participants who reach at least 75% reduction in EASI score from Baseline (EASI-75) at Week 12 4. Proportion of participants who achieve a ≥2-point reduction from Baseline in Validated Global Investigator Assessment Scale for Atopic Dermatitis (vIGA-AD) score and a score of 0 or 1 at Week 12, 5. Change and percent change from Baseline in PatientOriented Eczema Measure (POEM) at Week 12 6. Peak Pruritus Numerical Rating Scale (PP-NRS) response status defined as achieving weekly mean decrease from Baseline of ≥4 points at Week 12