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

Last updated: February 17, 2026
Sponsor: Inmagene LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy

Atopic Dermatitis

Dermatitis, Atopic

Treatment

Placebo

IMG-007

Clinical Study ID

NCT07037901
IMG-007-203
  • Ages 18-74
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  • Moderate-to-severe AD

  • Documented history of inadequate response or lack of tolerability to a stableregimen of one or more topical treatment before the Screening visit, or for whomtopical treatments are otherwise inadvisable

  • Female participants who are not pregnant or breastfeeding and meet at least one ofthe following conditions: not of childbearing potential or of childbearing potentialand 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

Exclusion

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 withthe assessment of AD based on the investigator's clinical judgement

  • Other conditions or laboratory abnormality that could increase the risk associatedwith study participation or could interfere with the interpretation of study resultsand, in the judgment of the investigator, would make the patient inappropriate forentry into the study

  • Having received any of the specified therapies within the specified timeframe(s)prior to the Baseline visit

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 17, 2025
Estimated Completion Date:
October 31, 2027

Study Description

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 52 weeks.

Connect with a study center

  • Dr. Chin-ho-Hong Medical Inc.

    Surrey 6159905, British Columbia 5909050 V3R 6A7
    Canada

    Active - Recruiting

  • PacificDerm

    Vancouver 6173331, British Columbia 5909050 V6H 4B1
    Canada

    Active - Recruiting

  • Sudbury Skin Clinique

    Greater Sudbury 5964700, Ontario 6093943 P3C 1X8
    Canada

    Active - Recruiting

  • DermEdge Research

    Mississauga 6075357, Ontario 6093943 L4Y 4C5
    Canada

    Active - Recruiting

  • North Bay Dermatology Centre

    North Bay 6089426, Ontario 6093943 P1B 3Z7
    Canada

    Active - Recruiting

  • Innovaderm Research Inc.

    Montreal 6077243, Quebec 6115047 H2X 2V1
    Canada

    Active - Recruiting

  • Skinsense Medical Research

    Saskatoon 6141256, Saskatchewan 6141242 S7K 2C1
    Canada

    Active - Recruiting

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Site Not Available

  • Antelope Valley Clinical Trials

    Lancaster 5364940, California 5332921 93534
    United States

    Active - Recruiting

  • UCLA Division of Dermatology

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research

    Tampa, Florida 33609
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala 4166673, Florida 4155751 34470
    United States

    Active - Recruiting

  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research

    Tampa 4174757, Florida 4155751 33609
    United States

    Active - Recruiting

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows 4908052, Illinois 4896861 60008
    United States

    Active - Recruiting

  • Forest Hills Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Forest Hills Dermatology Group

    Kew Gardens 5123344, New York 5128638 11415
    United States

    Active - Recruiting

  • Inmagene Site 1

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Vitality Clinical Trials LLC

    Woodbury 5144948, New York 5128638 11797
    United States

    Active - Recruiting

  • Darst Dermatology

    Charlotte 4460243, North Carolina 4482348 28277
    United States

    Active - Recruiting

  • Red River Research Partners, LLC

    Fargo 5059163, North Dakota 5690763 58103
    United States

    Active - Recruiting

  • ClinOhio Research Services LLC.

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Apex Clinical Research Center

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • ClinOhio Research Services LLC.

    Columbus 4509177, Ohio 5165418 43213
    United States

    Active - Recruiting

  • Apex Clinical Research Center

    Mayfield Heights 5162188, Ohio 5165418 44124
    United States

    Active - Recruiting

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Palmetto Clinical Trial Services, LLC

    Anderson 4569298, South Carolina 4597040 29621
    United States

    Active - Recruiting

  • Stryde Research-Epiphany Dermatology

    Southlake, Texas 76092
    United States

    Site Not Available

  • Stryde Research-Epiphany Dermatology

    Southlake 4733313, Texas 4736286 76092
    United States

    Active - Recruiting

  • Dermatology of Seattle & Bellevue

    Burien, Washington 698168
    United States

    Site Not Available

  • Dermatology of Seattle & Bellevue

    Burien 5788516, Washington 5815135 698168
    United States

    Active - Recruiting

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