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

NCT06060977 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IMG-007-202
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 17

Brief Summary

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

Conditions

Alopecia Areata (AA)

Keywords

IMG-007; Alopecia Areata; Alopecia; Hair Loss; Skin Disease; Immune System Disorder; Dermatologic Agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of Severity of Alopecia Tool (SALT)

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

Study Arms (2)

IMG-007 Dose 1 (300 mg)

EXPERIMENTAL

IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks

Drug: IMG-007

IMG-007 Dose 2 (600 mg)

EXPERIMENTAL

IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks

Drug: IMG-007

Interventions

IMG-007 DRUG

Intravenous Infusion

IMG-007 Dose 1 (300 mg); IMG-007 Dose 2 (600 mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inmagene LLC: lead

Study Sites (17)

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

Rogers, Arkansas, 72758, United States

Location

Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

Dawes Fretzin Clinical Resarch Group, LLC

Indianapolis, Indiana, 47906, United States

Location

Options Research Group

West Lafayette, Indiana, 47906, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01803, United States

Location

Great Lakes Research Group Inc.

Bay City, Michigan, 48706, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Stride Clinical Research LLC

Sugar Land, Texas, 77479, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

SimcoMed Health Ltd.

Barrie, Ontario, L4M7G1, Canada

Location

Skin Health

Cobourg, Ontario, K9A0Z4, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L0B7, Canada

Location

Research Toronto

Toronto, Ontario, M2W2N4, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W4R4, Canada

Location

Innovaderm Research Inc.

Montreal, Canada

Location

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Skin Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Lead
• Organization: Inmagene LLC

ClinicalTrials@imagenebio.com

(858) 345-6927

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 29, 2023
• Study Start: September 25, 2023
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Locations

CA (6); US (11)