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

NCT ID: NCT06060977

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-01-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Alopecia Areata (AA)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMG-007 Dose 1

IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Intravenous Infusion

IMG-007 Dose 2

IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Intravenous Infusion

Interventions

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IMG-007

Intravenous Infusion

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inmagene LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.

Rogers, Arkansas, United States

Site Status

Torrance Clinical Research Institute Inc.

Lomita, California, United States

Site Status

Alliance Clinical Research of Tampa

Tampa, Florida, United States

Site Status

Dawes Fretzin Clinical Resarch Group, LLC

Indianapolis, Indiana, United States

Site Status

Options Research Group

West Lafayette, Indiana, United States

Site Status

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Site Status

Great Lakes Research Group Inc.

Bay City, Michigan, United States

Site Status

Skin Cancer and Dermatology Institute

Reno, Nevada, United States

Site Status

Skin Search of Rochester, Inc.

Rochester, New York, United States

Site Status

Stride Clinical Research LLC

Sugar Land, Texas, United States

Site Status

Dermatology Specialists of Spokane

Spokane, Washington, United States

Site Status

SimcoMed Health Ltd.

Barrie, Ontario, Canada

Site Status

Skin Health

Cobourg, Ontario, Canada

Site Status

Guelph Dermatology Research

Guelph, Ontario, Canada

Site Status

Research Toronto

Toronto, Ontario, Canada

Site Status

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Site Status

Innovaderm Research Inc.

Montreal, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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IMG-007-202

Identifier Type: -

Identifier Source: org_study_id

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