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

RecruitingPhase 2

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

Who can join

Ages 18 to 74 · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Inmagene LLC · Participants: 405 · Started: Jun 17, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07037901

Locations in the U.S.

CaliforniaInmagene Site 1, Lancaster
Inmagene Site 23, Los Angeles
FloridaInmagene Site 19, Ocala
Inmagene Site 4, Tampa
IllinoisInmagene Site 2, Rolling Meadows
New YorkInmagene Site 6, Kew Gardens
Inmagene Site 21, New York
Inmagene Site 11, Woodbury
North CarolinaInmagene Site 20, Charlotte
North DakotaInmagene Site 10, Fargo
OhioInmagene Site 9, Columbus
Inmagene Site 5, Mayfield Heights
OregonInmagene Site 3, Portland
South CarolinaInmagene Site 12, Anderson
TexasInmagene Site 8, Southlake
WashingtonInmagene Site 7, Burien

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.