What side effects are associated with this type of intervention?

Common treatments for eczema include topical corticosteroids, phototherapy, and systemic treatments. Topical corticosteroids can cause local adverse events such as skin thinning, especially with higher-potency formulations. Phototherapy, including UVB and UVA treatments, generally has a good safety profile but may carry risks of skin aging and carcinogenesis with long-term use. Systemic treatments, such as methotrexate, can have a range of side effects including liver toxicity and bone marrow suppression. Newer biologic treatments and targeted therapies, like those being studied in the IMG-007 trial, aim to reduce inflammation with potentially fewer side effects, but comprehensive safety data is still being evaluated.

What prior FDA approvals exist?

Several treatments for atopic dermatitis have received FDA approval, focusing on biologics and immunomodulators. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is approved for moderate-to-severe atopic dermatitis. Topical calcineurin inhibitors like tacrolimus and pimecrolimus are also approved for eczema, working by modulating the immune response. These treatments share a similar goal with IMG-007, aiming to manage inflammation and immune dysregulation in atopic dermatitis.

What other types of research exist?

Promising novel alternatives to IMG-007 for treating atopic dermatitis in 2024 include: 1) Dupilumab, an IL-4/IL-13 inhibitor, which has shown long-term safety and efficacy in both children and adults with moderate-to-severe atopic dermatitis. 2) Nemolizumab, an anti-IL-31 receptor A antibody, which has demonstrated significant reduction in pruritus in clinical trials. 3) Lebrikizumab, an anti-IL-13 antibody, which has shown efficacy in reducing inflammation and barrier dysfunction in atopic dermatitis patients.

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IMG-007 for Atopic Dermatitis/Eczema

Q: What is the mechanism of action of this treatment?

Common treatments for eczema, such as phototherapy, melatonin, and barrier-strengthening moisturizers, work through different mechanisms to alleviate symptoms. Phototherapy, including UVB and UVA, reduces inflammation and modulates the immune response, which helps in decreasing the severity of eczema. Melatonin, known for its antioxidant and anti-inflammatory properties, can improve sleep and reduce disease severity. Barrier-strengthening moisturizers help maintain skin hydration and integrity, preventing flare-ups. Understanding these mechanisms is crucial for eczema patients as it helps in selecting appropriate treatments that target specific aspects of the disease, potentially improving outcomes and quality of life.

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 < 75 years

Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable

Must not have

Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit

Evidence of active or latent tuberculosis (TB)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Summary

This trial tests IMG-007, a new drug, in adults with severe skin issues. It aims to see if the drug is safe and effective by administering it and monitoring its effects on the body and the skin condition.

Who is the study for?

Adults aged 18-75 with moderate-to-severe Atopic Dermatitis (AD) who haven't responded well to topical treatments can join this trial. Participants must not be pregnant or breastfeeding and agree to use effective contraception. Those with active infections, TB, hepatitis B/C, HIV, or other skin conditions that could affect the study's results are excluded.

What is being tested?

The trial is testing IMG-007 against a placebo in adults with AD. It aims to check how safe IMG-007 is, how the body processes it (pharmacokinetics), and if it's effective in improving symptoms of AD.

What are the potential side effects?

While specific side effects for IMG-007 aren't listed here, common ones for new AD treatments may include skin irritation at the application site, headaches, cold-like symptoms and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 75 years old.

Select...

Topical treatments have not worked for me or I cannot use them.

Exclusion Criteria

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

Select...

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

Select...

I have signs of active or dormant TB.

Select...

I have hepatitis B, C, or HIV.

Select...

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

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 Eczema Area and Severity Index (EASI)

Pharmacokinetic Characterization

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

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

Group III: PlaceboPlacebo Group1 Intervention

Placebo 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 / 6Eligibility 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

Common treatments for eczema, such as phototherapy, melatonin, and barrier-strengthening moisturizers, work through different mechanisms to alleviate symptoms. Phototherapy, including UVB and UVA, reduces inflammation and modulates the immune response, which helps in decreasing the severity of eczema. Melatonin, known for its antioxidant and anti-inflammatory properties, can improve sleep and reduce disease severity. Barrier-strengthening moisturizers help maintain skin hydration and integrity, preventing flare-ups. Understanding these mechanisms is crucial for eczema patients as it helps in selecting appropriate treatments that target specific aspects of the disease, potentially improving outcomes and quality of life.

Combined UVB and UVA phototherapy of atopic eczema.Potential effects and mechanisms of Chinese herbal medicine in the treatment of psoriasis.Interventions for erythema multiforme: a systematic review.