IMG-007 for Alopecia Areata

Recruiting at 16 trial locations

Overseen By Duong Nguyen

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Inmagene LLC

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Hepatitis, HIV, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called IMG-007 to see if it is safe and effective for adults with significant hair loss due to Alopecia Areata. The medicine likely helps protect hair follicles from immune system attacks, allowing hair to grow back.

Eligibility Criteria

This trial is for adults aged 18 to 65 with Alopecia Areata (AA) who have lost more than half of their scalp hair for over 6 months but less than 8 years. Candidates should not have active infections, hepatitis B/C, HIV, TB, or other conditions that cause hair loss or could risk the study's safety.

Inclusion Criteria

My current episode of hair loss has lasted more than 6 months but less than 8 years.

Over half of my scalp has hair loss.

Exclusion Criteria

I have signs of active or dormant TB.

I have had TB that was not treated or not treated well.

I have had hair transplants or scalp micropigmentation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 5 weeks

Treatment

Participants receive three intravenous infusions of IMG-007 over 4 weeks

16 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Treatment Details

Interventions

• IMG-007

Trial Overview The trial is testing the safety and effectiveness of a new treatment called IMG-007 specifically for adults with severe AA. The main goal is to see how safe it is and how the body processes it.

Participant Groups

Group I: IMG-007 Dose 2 Experimental Treatment 1 Intervention

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

Group II: IMG-007 Dose 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Inmagene LLC

Lead Sponsor

Trials

6

Recruited

200+