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

Launched by INMAGENE LLC · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called IMG-007 to see if it is safe and effective for adults with moderate-to-severe atopic dermatitis, which is a type of eczema that causes itchy, inflamed skin. The study will compare different doses of IMG-007 to a placebo (a treatment with no active medicine) to find out if IMG-007 can help improve symptoms like itching and skin rash.

Adults who have moderate-to-severe atopic dermatitis and have not had enough relief from or cannot tolerate usual skin treatments may be eligible to join. To qualify, participants need to have significant skin involvement (affecting at least 10% of their body) and moderate-to-severe symptoms measured by specific skin scores. Women who can become pregnant and men must agree to use effective birth control during the study. Participants will be carefully screened to make sure they do not have certain infections or other health problems that could affect the study or their safety. Those who join can expect to be monitored closely to check how well the medicine works and to watch for any side effects. This study is not yet open for enrolling participants.

Gender

ALL

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 antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
• • Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement
• • Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study
• • Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit