IMG-007 for Alopecia Areata

No longer recruiting at 17 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMG-007 for individuals with Alopecia Areata, a condition that causes hair loss. The primary aim is to determine if IMG-007 is safe for adults who have lost at least 50% of their scalp hair due to this condition. Participants will receive one of two different doses of IMG-007, administered intravenously three times over four weeks. Those experiencing ongoing hair loss for more than six months but less than eight years, with at least half of their scalp affected, may be suitable candidates. As a Phase 1 trial, this research focuses on understanding how IMG-007 works in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that IMG-007 is likely to be safe for humans?

Research shows that IMG-007 has been tested for safety in people with alopecia areata, a condition that causes hair loss. In earlier studies, participants tolerated the treatment well, and no serious unwanted effects were reported. This is encouraging for those considering joining the trial, as past findings suggest the treatment is safe. Additionally, the treatment is being studied in a setting that prioritizes safety, with close monitoring of any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for alopecia areata focus on suppressing the immune response or stimulating hair follicles, but IMG-007 offers a novel approach. Researchers are excited about IMG-007 because it introduces a new active ingredient designed to target specific pathways involved in hair loss more directly. Unlike current options that may take longer to deliver results, IMG-007 is administered intravenously, potentially allowing for faster and more consistent delivery of the treatment. This innovative approach might lead to quicker and more effective results for patients struggling with alopecia areata.

What evidence suggests that IMG-007 might be an effective treatment for Alopecia Areata?

Research shows that IMG-007 may help treat alopecia areata, a condition that causes hair loss. In earlier studies, patients experienced hair regrowth and reduced hair loss, as measured by their Severity of Alopecia Tool (SALT) scores. This indicates they lost less hair after treatment. The treatment works by affecting OX40, a part of the immune system. In this trial, participants will receive either IMG-007 Dose 1 or IMG-007 Dose 2. Previous studies showed that higher doses led to even better results, indicating that the effect depends on the dose. These findings suggest IMG-007 could be a good option for people with severe hair loss due to alopecia areata. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. imagenebio.com imagenebio.com/press_releases/inmagene-reports-topline-results-from-phase-2a-study-of-img-007-a-nondepleting-anti-ox40-monoclonal-antibody-with-an-extended-half-life-in-patients-with-alopecia-areata/

Inmagene Reports Topline Results from Phase 2a Study of ... Patients in Cohort 2 showed a sustained improvement in Severity of Alopecia Tool (SALT) score, which did not plateau by Week 36, approximately ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06060977?term=AREA%5BConditionSearch%5D(Alopecia)&rank=8

NCT06060977 | A Study to Evaluate the Safety, ... 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 ...

3. hcplive.com hcplive.com/view/topline-results-released-on-img-007-monoclonal-antibody-alopecia-areata

Topline Results Released on IMG-007 Monoclonal ... IMG-007, targeting OX40, showed dose-related hair regrowth and SALT score improvements in severe alopecia areata patients. The higher-dose ...

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/inmagene-img-007-shows-promise-in-alopecia-areata-phase-2a-study/

Inmagene: IMG-007 Shows Promise in Alopecia Areata ... IMG-007, administered intravenously over just four weeks, offers the potential for a less frequent, safer, and more effective long-term ...

5. inmagenebio.com inmagenebio.com/press_releases/inmagene-doses-first-patient-in-phase-2a-trial-of-img-007-an-anti-ox40-monoclonal-antibody-with-an-extended-half-life-for-the-treatment-of-alopecia-areata/

Inmagene Doses First Patient in Phase 2a Trial of IMG-007, ... ... Alopecia Areata. IMG-007 is a novel anti-OX40 monoclonal antibody (mAb) engineered for potentially once every 12 weeks dosing and an improved safety profile.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06060977

NCT06060977 | A Study to Evaluate the Safety, ... 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 ...

7. naaf.org naaf.org/studies/img-007-study-alopecia-areata/

A Phase 1b/2a Study to Evaluate the Safety, ... This study aims to evaluate the safety and efficacy of an investigational drug called IMG-007 in people with alopecia areata.