NCT06060977

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Inmagene LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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 a 20-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.

Conditions

• Alopecia Areata (AA)

Interventions

Type	Name	Description
DRUG	IMG-007	Intravenous Infusion

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2023-09-29
• Last updated: 2026-02-09
• Results posted: 2026-02-09

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study