Skip to main content
OpenTrials
Completed

NCT Number: NCT06060977

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SimcoMed Health Ltd., Barrie, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMG-007

Drug

Intravenous Infusion

Primary outcomes

  1. Evaluation of Adverse Events in Participants

    Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.

    To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.

Secondary outcomes

  1. Evaluation of Severity of Alopecia Tool (SALT)

    Time frame: Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.

    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).

Sponsors and collaborators

Lead sponsor

Inmagene LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.