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

Inmagene

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Alopecia Areata (AA)

Treatments: Drug: IMG-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT06060977

IMG-007-202

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

IMG-007 Dose 1

Experimental group

Description:

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

Treatment:

Drug: IMG-007

IMG-007 Dose 2

Experimental group

Description:

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

Treatment:

Drug: IMG-007