What side effects are associated with this type of intervention?

Common treatments for eczema with anti-inflammatory or immunomodulatory effects include topical corticosteroids, topical calcineurin inhibitors, JAK inhibitors, and monoclonal antibodies. Topical corticosteroids can cause skin thinning, stretch marks, and increased risk of skin infections. Topical calcineurin inhibitors like tacrolimus and pimecrolimus may cause burning or itching at the application site and a potential increased risk of skin infections. JAK inhibitors, such as baricitinib, can lead to nasopharyngitis and headaches. Monoclonal antibodies like dupilumab and nemolizumab are generally well-tolerated but can cause mild side effects such as injection site reactions, conjunctivitis, and nasopharyngitis.

What prior FDA approvals exist?

The FDA has approved several treatments for eczema, particularly those with anti-inflammatory or immunomodulatory effects. Dupilumab, an IL-4 receptor alpha antagonist, is one such drug approved for moderate-to-severe atopic dermatitis in various age groups, including children and adolescents. Other treatments include topical corticosteroids, which reduce inflammation, and calcineurin inhibitors like tacrolimus and pimecrolimus, which modulate the immune response. These treatments aim to alleviate symptoms by targeting the underlying inflammatory processes of eczema.

What other types of research exist?

Promising novel alternatives for eczema treatment in 2024 include: 1) Apremilast, an oral phosphodiesterase 4 inhibitor, which has shown preliminary safety and efficacy in reducing symptoms of atopic dermatitis. 2) Nemolizumab, targeting the IL-31 receptor α subunit, which has demonstrated efficacy in reducing severe pruritus and symptoms in moderate-to-severe atopic dermatitis. 3) Dupilumab, which blocks IL-4 and IL-13 signaling, has shown acceptable safety and effectiveness in various studies, including those focused on skin of color participants.

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Monoclonal Antibodies

Dupilumab for Eczema (DISCOVER Trial)

Phase 4

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol

Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit

Must not have

Adolescent body weight less than 30 kg at screening

Concomitant skin diseases or other pigmentary disorder that could confound AD assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a medication for treating eczema in people with skin of color. Eczema causes itchy, dry, and cracked skin. The medication aims to reduce these symptoms by calming the immune system. The study will also look at side effects, how much of the drug is in the blood at different times, and improvements in quality of life and mental health.

Who is the study for?

This trial is for adolescents and adults with darker skin (Fitzpatrick skin type ≥4) who suffer from moderate-to-severe eczema that isn't well-managed by topical treatments. Participants should be using a stable dose of moisturizer as recommended by their physician. Excluded are those who've used dupilumab recently, had certain vaccinations close to the trial start, or have other skin conditions that might affect results.

What is being tested?

The study tests Dupilumab's safety and effectiveness in improving life quality and mental health for people with colored skin suffering from severe eczema. It also examines how much of the drug gets into the blood over time. Participants will use Dupilumab alongside regular moisturizers to manage their eczema symptoms.

What are the potential side effects?

Potential side effects may include reactions at the injection site, eye issues like redness or itching, cold sores in your mouth or on your lips, and inflammation of organs similar to previous studies on participants with atopic dermatitis.

Eligibility Criteria

Inclusion Criteria

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

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My severe skin condition isn't controlled by creams or ointments.

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I have been using a moisturizer as recommended by my doctor.

Exclusion Criteria

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

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I weigh less than 30 kg.

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I do not have skin conditions that could affect skin assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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

Proportion of participants with eczema area and severity index (EASI)-75

Secondary study objectives

Absolute change from baseline in EASI

Absolute change from baseline in weekly average of daily PP NRS

Change from baseline in Hospital Anxiety and Depression Scale (HADS)

+21 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: dupilumabExperimental Treatment2 Interventions

Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dupilumab

2023

Completed Phase 4

~470

0 / 4Eligibility 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 primarily work through anti-inflammatory and immunomodulatory mechanisms. Topical corticosteroids reduce inflammation by suppressing the immune response in the skin. Topical immunomodulators like tacrolimus and pimecrolimus inhibit calcineurin, which decreases the activity of T-cells and reduces inflammation. Systemic treatments such as dupilumab and lebrikizumab target specific cytokines involved in the inflammatory process; dupilumab blocks IL-4 and IL-13 signaling, while lebrikizumab inhibits IL-13. These mechanisms are crucial for eczema patients as they directly address the underlying inflammation and immune dysregulation, leading to symptom relief and improved skin condition.

Treatment of atopic dermatitis with antihistamines: lessons from a single-patient, randomized clinical trial.Systemic Immunomodulatory Treatments for Patients With Atopic Dermatitis: A Systematic Review and Network Meta-analysis.Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.