What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata that involve immune modulation include corticosteroids, cyclosporine, and JAK inhibitors. Corticosteroids can cause side effects such as skin thinning, weight gain, and increased risk of infections. Cyclosporine may lead to serious adverse effects like kidney damage, hypertension, and increased risk of infections, making it unsuitable for long-term use. JAK inhibitors, such as tofacitinib, can cause diarrhea, liver enzyme elevation, pancreatitis, and bone marrow suppression. These side effects often necessitate discontinuation of treatment in some patients.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for alopecia areata that focus on immune modulation or hair follicle protection. However, treatments such as JAK inhibitors (e.g., tofacitinib), cyclosporine, and dupilumab have shown potential benefits in clinical studies and case reports. These treatments are being actively researched, and there is hope that a JAK inhibitor may soon receive FDA approval for alopecia areata.

What other types of research exist?

Promising alternatives to IMG-007 for Alopecia Areata patients include: 1) Tofacitinib, an oral Janus kinase (JAK) inhibitor, which has shown efficacy in multiple studies for moderate to severe AA. 2) CTP-543, another JAK inhibitor, which has demonstrated safety and efficacy in a phase 2 trial. 3) Topical diphencyprone, which has been effective in reversing AA-like hair loss in animal models. These treatments represent novel and promising options for AA patients considering treatment in 2024.

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IMG-007 for Alopecia Areata

Phase 1 & 2

Waitlist Available

Research Sponsored by Inmagene LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged ≥ 18 and ≤ 65 years

AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50

Must not have

Evidence of active or latent tuberculosis (TB)

History of untreated or inadequately treated TB infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones in trials like this may include skin reactions at the application site, headaches, fatigue, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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Over half of my scalp has hair loss.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have signs of active or dormant TB.

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

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I have had hair transplants or scalp micropigmentation.

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I am not on treatment for an active infection with antibiotics or other similar drugs.

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I do not have scalp conditions that could affect hair loss evaluation.

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My condition is the 'diffuse' type of astrocytoma.

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I am experiencing hair loss not related to cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of Adverse Events in Participants

Secondary study objectives

Evaluation of Severity of Alopecia Tool (SALT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: IMG-007 Dose 2Experimental Treatment1 Intervention

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

Group II: IMG-007 Dose 1Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMG-007

2024

Completed Phase 1

~20

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Alopecia Areata is primarily driven by an autoimmune response where cytotoxic T lymphocytes attack hair follicles. Treatments like JAK inhibitors (e.g., tofacitinib) work by modulating the immune system to reduce this attack, thereby promoting hair regrowth. Other treatments, such as cyclosporine, also suppress the immune response but come with significant side effects. Platelet-rich plasma (PRP) therapy, which contains growth factors, supports hair follicle health and reduces inflammation. These treatments are crucial for patients as they target the underlying autoimmune mechanisms, offering potential for more effective and sustained hair regrowth.