A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of IMG-007 in Adults With Moderate-to-Severe Atopic Dermatitis

What this Trial Is About

Researchers are evaluating the efficacy and safety of different dose regimens of IMG-007 in adults with moderate-to-severe active atopic dermatitis (AD). This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study aims to assess the effects of IMG-007 compared to placebo over up to 48 weeks. The study targets adults with significant AD symptoms who have not responded well to topical treatments or cannot use them. Participants will receive subcutaneous injections of IMG-007 at various doses or placebo according to the study protocol. Those initially receiving placebo may later switch to IMG-007. The treatment period lasts up to 48 weeks, with dosing and administration closely monitored. The study includes multiple experimental groups with different IMG-007 dose regimens and placebo comparator groups. During the study, participants will have regular assessments including skin evaluations, symptom scales such as the Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (vIGA-AD), and safety monitoring for adverse events. The primary outcome is the mean percent change in EASI score at Week 24. Secondary outcomes include various measures of symptom improvement and safety. Participants will be followed through the treatment and assessment periods to evaluate response and tolerability.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis