Study to Evaluate Safety and Effectiveness of Oral ENV-294 in Adults with Moderate-to-Severe Atopic Dermatitis Comparing Multiple Doses to Placebo

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ENV-294, an oral investigational drug, in adults with moderate-to-severe atopic dermatitis AD. This double-blind, placebo-controlled Phase 2b study compares three different doses of ENV-294 against a placebo over 12 weeks. The study aims to better understand how ENV-294 affects disease severity, symptoms, quality of life, and biological markers in people with chronic AD. Participants will be randomly assigned to one of four groups receiving either one of three doses of ENV-294 or a matching placebo. The treatment is taken once daily by mouth for 12 weeks. Before starting treatment, participants undergo screening to confirm eligibility based on their AD diagnosis, disease severity, and treatment history. During the study, participants complete regular assessments of their eczema severity using standardized scores like the Eczema Area and Severity Index EASI, patient-reported outcomes, safety checks, blood tests for drug levels, and biomarker analysis. Researchers monitor for any adverse events throughout the 12 weeks and for an additional 4 weeks following treatment. The total participation time includes screening, treatment, and follow-up assessments to evaluate both the effects and safety of ENV-294.

A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis