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

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

Phase 2 Interventional Inmagene LLC · NCT07037901

This study will test if different doses of IMG-007 reduce skin inflammation and itching in adults with moderate-to-severe atopic dermatitis compared with a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorInmagene LLC Industry-sponsored
Locations23 sites (Lancaster, California and 22 other locations)
Trial IDNCT07037901 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate-to-severe active atopic dermatitis who have significant itch and an inadequate response or intolerance to topical treatments and who meet objective criteria such as EASI ≥16, vIGA-AD ≥3, ≥10% BSA affected, and mean peak pruritus NRS ≥4.

Not a fit: Patients with active infections or positive hepatitis B/C or HIV tests, evidence of active or latent tuberculosis, or other exclusionary conditions are unlikely to benefit from participation and may be ineligible.

Why it matters

Potential benefit: If successful, IMG-007 could offer a new systemic option that reduces skin inflammation and itching for adults with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other systemic and biologic therapies have demonstrated benefit in moderate-to-severe atopic dermatitis, but IMG-007 appears to be a novel agent and this Phase 2b trial is testing its specific effectiveness and safety profile.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Lancaster, California and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisAtopic Dermatitis EczemaEczemaIMG-007Dermatitis, AtopicDermatitisSkin DiseasesImmune System Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.