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

Alopecia Areata (AA) Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06060977
• Other study ID #: IMG-007-202
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 25, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Inmagene LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia Areata (AA)

Intervention

Drug:
• IMG-007
Intravenous Infusion

Locations

Country	Name	City	State
Canada	SimcoMed Health Ltd.	Barrie	Ontario
Canada	Skin Health	Cobourg	Ontario
Canada	Guelph Dermatology Research	Guelph	Ontario
Canada	Innovaderm Research Inc.	Montréal
Canada	Centre de Recherche Saint-Louis	Québec	Quebec
Canada	Research Toronto	Toronto	Ontario
United States	Great Lakes Research Group Inc.	Bay City	Michigan
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	Dawes Fretzin Clinical Resarch Group, LLC	Indianapolis	Indiana
United States	Torrance Clinical Research Institute Inc.	Lomita	California
United States	Skin Cancer and Dermatology Institute	Reno	Nevada
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.	Rogers	Arkansas
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Stride Clinical Research LLC	Sugar Land	Texas
United States	Alliance Clinical Research of Tampa	Tampa	Florida
United States	Options Research Group	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Inmagene LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Adverse Events in Participants	To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.	Baseline, Week 24
Secondary	Pharmacokinetic characterization	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
Secondary	Pharmacokinetic characterization	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
Secondary	Evaluation of Severity of Alopecia Tool (SALT)	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