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

Study Overview
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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 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.

Official Title
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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

Conditions
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Alopecia Areata (AA)

Intervention / Treatment
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* Drug: IMG-007


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMG-007 Dose 1<br>IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks | Drug: IMG-007<br>* Intravenous Infusion<br>|
| Experimental: IMG-007 Dose 2<br>IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks | Drug: IMG-007<br>* Intravenous Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMG-007, Alopecia Areata, Alopecia, Hair Loss, Skin Disease, Immune System Disorder, Dermatologic Agents