A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

Last updated: December 19, 2024
Sponsor: Inmagene LLC
Overall Status: Terminated

Phase

1/2

Condition

Atopic Dermatitis

Rash

Allergy

Treatment

Placebo

IMG-007

Clinical Study ID

NCT05984784
IMG-007-201
  • Ages 18-74
  • All Genders

Study Summary

The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female aged ≥ 18 and < 75 years.

  • 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.

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.

  • 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.

Study Design

Total Participants: 13
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
August 09, 2023
Estimated Completion Date:
April 26, 2024

Study Description

This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.

Connect with a study center

  • Brunswick Dermatology Center

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • DermEffects

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis (Québec)

    Québec, G1W4R4
    Canada

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Site Not Available

  • Amicis Research Center

    Valencia, California 91355
    United States

    Site Not Available

  • Medical Research Center of Miami II Inc

    Miami, Florida 33134
    United States

    Site Not Available

  • Optimal Research Sites

    Orange City, Florida 32763
    United States

    Site Not Available

  • USF Carol and Frank Morsani Center for Advanced Healthcare

    Tampa, Florida 33612
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Markowitz Medical, LLC

    New York, New York 10128
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73170
    United States

    Site Not Available

  • Paddington Testing Co, Inc

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.