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Recruiting Phase 2 NCT07037901

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

Trial Parameters

Condition Atopic Dermatitis
Sponsor Inmagene LLC
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 220
Sex ALL
Min Age 18 Years
Max Age 74 Years
Start Date 2025-06-17
Completion 2026-11
Interventions
IMG-007Placebo

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.

Eligibility Criteria

Key Inclusion Criteria: * Moderate-to-severe AD * Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable * Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception * Male participants must agree to use a highly effective method of contraception * EASI score ≥16 * vIGA-AD score ≥3 * ≥10% body surface area (BSA) of AD involvement * Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization Key Exclusion Criteria: * Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection * Evidence of active or latent tuberculosis (TB) * History of untreated or inadequately treated TB infection * Active infection requiring treatment with systemic a

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