A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants

Last updated: August 28, 2024
Sponsor: Inmagene LLC
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Hair Loss

Alopecia

Treatment

IMG-007

Clinical Study ID

NCT06060977
IMG-007-202
  • Ages 18-65
  • All Genders

Study Summary

The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female aged ≥ 18 and ≤ 65 years

  • AA with current episode of hair loss of > 6 months but < 8 years

  • AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50

Exclusion

Key Exclusion Criteria:

  • Known 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 at the Screening visit

  • Concurrent hair loss due to other etiologies

  • Primary "diffuse" type of AA

  • Active inflammatory diseases on the scalp that would interfere with the assessmentof AA

  • History or presence of hair transplants or micropigmentation of the scalp

  • Active systemic diseases that may cause hair loss

  • 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.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: IMG-007
Phase: 1/2
Study Start date:
September 25, 2023
Estimated Completion Date:
January 31, 2025

Study Description

This is a phase 1b/2a, open label study to assess the safety, PK, and efficacy of IMG-007 in adult AA participants with 50% or greater scalp hair loss. The study will consist of two cohorts with three periods: a screening period of up to 5 -weeks, a 16-week treatment period and a 20-week follow- up period. Approximately 6 and 24 participants will be sequentially enrolled into cohort 1 and cohort 2, respectively, to receive three intravenous infusions of IMG-007 over 4 weeks.

Connect with a study center

  • SimcoMed Health Ltd.

    Barrie, Ontario L4M7G1
    Canada

    Site Not Available

  • Skin Health

    Cobourg, Ontario K9A0Z4
    Canada

    Site Not Available

  • Guelph Dermatology Research

    Guelph, Ontario N1L0B7
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M2W2N4
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Québec, Quebec G1W4R4
    Canada

    Site Not Available

  • Innovaderm Research Inc.

    Montréal,
    Canada

    Site Not Available

  • Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Torrance Clinical Research Institute Inc.

    Lomita, California 90717
    United States

    Site Not Available

  • Alliance Clinical Research of Tampa

    Tampa, Florida 33615
    United States

    Site Not Available

  • Dawes Fretzin Clinical Resarch Group, LLC

    Indianapolis, Indiana 47906
    United States

    Site Not Available

  • Options Research Group

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts 01803
    United States

    Site Not Available

  • Great Lakes Research Group Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute

    Reno, Nevada 89509
    United States

    Site Not Available

  • Skin Search of Rochester, Inc.

    Rochester, New York 14623
    United States

    Site Not Available

  • Stride Clinical Research LLC

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

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