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

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: Completed
• Conditions: Alopecia Areata (AA)
• Intervention / Treatment: Drug: IMG-007

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 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada
    • Innovaderm Research Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M7G1
      • SimcoMed Health Ltd.
    • Cobourg, Ontario, Canada, K9A0Z4
      • Skin Health
    • Guelph, Ontario, Canada, N1L0B7
      • Guelph Dermatology Research
    • Toronto, Ontario, Canada, M2W2N4
      • Research Toronto
  • Quebec
    • Québec, Quebec, Canada, G1W4R4
      • Centre de Recherche Saint-Louis
• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
  • California
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute Inc.
  • Florida
    • Tampa, Florida, United States, 33615
      • Alliance Clinical Research of Tampa
  • Indiana
    • Indianapolis, Indiana, United States, 47906
      • Dawes Fretzin Clinical Resarch Group, LLC
    • West Lafayette, Indiana, United States, 47906
      • Options Research Group
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Lahey Hospital & Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group Inc.
  • Nevada
    • Reno, Nevada, United States, 89509
      • Skin Cancer and Dermatology Institute
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • Texas
    • Sugar Land, Texas, United States, 77479
      • Stride Clinical Research LLC
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMG-007 Dose 1 (300 mg); IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks	Drug: IMG-007; Intravenous Infusion
Experimental: IMG-007 Dose 2 (600 mg); IMG-007 Dose 2 (600 mg) 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	To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.	Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Severity of Alopecia Tool (SALT)	To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by the Severity of Alopecia Tool (SALT). The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. 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).	Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.

Collaborators and Investigators

• Sponsor: Inmagene LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): January 14, 2025
• Study Completion (Actual): January 14, 2025

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 (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Alopecia; Hair Loss; Alopecia Areata; Dermatologic Agents; Skin Disease; Immune System Disorder; IMG-007
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia Areata; Alopecia; Skin Diseases; Immune System Diseases
• 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
• product manufactured in and exported from the U.S.: No