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

March 19, 2024 updated by: Inmagene LLC

A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Québec, Canada, G1W4R4
        • Centre de Recherche Saint-Louis (Quebec)
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Brunswick Dermatology Center
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • Dermeffects
  • United States
    • California
      • Northridge, California, United States, 91324
        • Amicis Research Center
      • Valencia, California, United States, 91355
        • Amicis Research Center
    • Florida
      • Miami, Florida, United States, 33134
        • Medical Research Center of Miami II Inc
      • Orange City, Florida, United States, 32763
        • Optimal Research Sites
      • Tampa, Florida, United States, 33612
        • USF Carol and Frank Morsani Center for Advanced Healthcare
    • Michigan
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, LLC
    • New York
      • New York, New York, United States, 10128
        • Markowitz Medical, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73170
        • Central Sooner Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMG-007 Dose 1
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
Drug: IMG-007
Drug: IMG-007 Intravenous Infusion
Experimental: IMG-007 Dose 2
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Drug: IMG-007
Drug: IMG-007 Intravenous Infusion
Placebo Comparator: Placebo
Placebo will be administered intravenously 3 times over 4 weeks
Drug: Placebo
Drug: Placebo Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Adverse Events in Participants
Time Frame: Baseline, Week 24
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Characterization
Time Frame: Baseline, Week 24
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants
Baseline, Week 24
Pharmacokinetic Characterization
Time Frame: Baseline, Week 24
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants
Baseline, Week 24
Evaluation of Eczema Area and Severity Index (EASI)
Time Frame: Baseline, Week 12
To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inmagene LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMG-007-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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