IMG-007 for adults with moderate-to-severe atopic dermatitis.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will compare several dose regimens of IMG-007 against placebo in adults with moderate-to-severe active atopic dermatitis over up to 52 weeks. Participants will be enrolled at U.S. clinical sites and randomized to receive IMG-007 or placebo while investigators and participants remain blinded to treatment assignment. Key eligibility includes objective measures of disease severity such as EASI ≥16, vIGA-AD ≥3, at least 10% body surface area involvement, and mean peak pruritus NRS ≥4 despite prior topical therapy. Safety and efficacy endpoints will be collected throughout the treatment period to characterize both therapeutic effect and adverse events across dose groups.

Why it matters

Who can join: the full rules

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

Where it's running

• Inmagene Site 1
  Lancaster, California, United States Recruiting
• Inmagene Site 23
  Los Angeles, California, United States Recruiting
• Inmagene Site 19
  Ocala, Florida, United States Recruiting
• Inmagene Site 4
  Tampa, Florida, United States Recruiting
• Inmagene Site 2
  Rolling Meadows, Illinois, United States Recruiting
• Inmagene Site 6
  Kew Gardens, New York, United States Recruiting

Study contacts

• Study coordinator: ADAPTIVE Study Lead
• Email: ADAPTIVE_StudyLead@imagenebio.com
• Phone: (858) 345-6927

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.