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

Sponsor

Inmagene LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06060977

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

3.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata (AA)	Drug: IMG-007	Phase 1/Phase 2

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMG-007 Dose 1 IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks	Drug: IMG-007 Intravenous Infusion
Experimental: IMG-007 Dose 2 IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks	Drug: IMG-007 Intravenous Infusion

Arm

Intervention/Treatment

Experimental: IMG-007 Dose 1

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

Drug: IMG-007

Intravenous Infusion

Experimental: IMG-007 Dose 2

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

Drug: IMG-007

Intravenous Infusion

Outcome Measures

Primary Outcome Measures

Evaluation of Adverse Events in Participants [Baseline, Week 24]
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.

Secondary Outcome Measures

Pharmacokinetic characterization [Baseline, Week 24]
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AA participants.
Pharmacokinetic characterization [Baseline, Week 24]
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AA participants.
Evaluation of Severity of Alopecia Tool (SALT) [Baseline, Week 16]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Torrance Clinical Research Institute Inc.	Lomita	California	United States	90717
2	Dawes Fretzin Clinical Resarch Group, LLC	Indianapolis	Indiana	United States	47906
3	Options Research Group	West Lafayette	Indiana	United States	47906
4	Stride Clinical Research LLC	Sugar Land	Texas	United States	77479
5	Skin Health	Cobourg	Ontario	Canada	K9A0Z4
6	Guelph Dermatology Research	Guelph	Ontario	Canada	N1L0B7
7	Research Toronto	Toronto	Ontario	Canada	M2W2N4
8	Centre de Recherche Saint-Louis	Québec	Quebec	Canada	G1W4R4
9	Innovaderm Research Inc.	Montréal		Canada