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

March 4, 2024 updated by: Inmagene LLC

A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 an 8-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.

Study Type

Interventional

Enrollment (Estimated)

30

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
      • Montréal, Canada
        • Recruiting
        • Innovaderm Research Inc.
    • Ontario
      • Barrie, Ontario, Canada, L4M7G1
        • Recruiting
        • SimcoMed Health Ltd.
      • Cobourg, Ontario, Canada, K9A0Z4
        • Recruiting
        • Skin Health
      • Guelph, Ontario, Canada, N1L0B7
        • Recruiting
        • Guelph Dermatology Research
      • Toronto, Ontario, Canada, M2W2N4
        • Recruiting
        • Research Toronto
    • Quebec
      • Québec, Quebec, Canada, G1W4R4
        • Recruiting
        • Centre de Recherche Saint-Louis
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
    • California
      • Lomita, California, United States, 90717
        • Recruiting
        • Torrance Clinical Research Institute Inc.
    • Florida
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Alliance Clinical Research of Tampa
    • Indiana
      • Indianapolis, Indiana, United States, 47906
        • Recruiting
        • Dawes Fretzin Clinical Resarch Group, LLC
      • West Lafayette, Indiana, United States, 47906
        • Recruiting
        • Options Research Group
    • Massachusetts
      • Burlington, Massachusetts, United States, 01803
        • Not yet recruiting
        • Lahey Hospital & Medical Center
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • Great Lakes Research Group Inc.
    • Nevada
      • Reno, Nevada, United States, 89509
        • Not yet recruiting
        • Skin Cancer and Dermatology Institute
    • New York
      • Rochester, New York, United States, 14623
        • Recruiting
        • Skin Search of Rochester, Inc.
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Stride Clinical Research LLC
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Dermatology Specialists of Spokane

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 ≤ 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

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 assessment of 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 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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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
Intravenous Infusion
Experimental: IMG-007 Dose 2
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Drug: IMG-007
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 AA.
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 AA 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 AA participants.
Baseline, Week 24
Evaluation of Severity of Alopecia Tool (SALT)
Time Frame: Baseline, Week 16
To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by Severity of Alopecia Tool (SALT) on a scale of 0 for no hair loss, and 100 is complete hair loss (higher scores attributes to worse outcomes).
Baseline, Week 16

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)

September 25, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMG-007-202

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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