What is the mechanism of action of this treatment?

Common treatments for eczema, particularly systemic immunomodulatory treatments like Nemolizumab, work by targeting specific cytokines or receptors involved in the inflammatory pathways of the disease. Nemolizumab, for example, targets the IL-31 receptor, which plays a significant role in the itch-scratch cycle of eczema. Other treatments, such as Dupilumab, target the IL-4 and IL-13 pathways, reducing inflammation and improving skin barrier function. These mechanisms are important for patients to understand as they explain how these treatments can alleviate symptoms, reduce flare-ups, and enhance overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for eczema, particularly those involving monoclonal antibodies like Nemolizumab (which targets the IL-31 receptor), include drugs such as dupilumab and abrocitinib. The known side effects of these treatments can include injection site reactions, headache, nasopharyngitis, and nausea. Dupilumab has also been associated with conjunctivitis and facial redness. Abrocitinib may cause acne and has been linked to more serious adverse effects such as cardiorespiratory arrest and intracranial hemorrhage in rare cases. Overall, while these treatments can be effective, they come with a range of potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for eczema, particularly for moderate-to-severe cases. Dupilumab, a monoclonal antibody that targets the IL-4 and IL-13 pathways, is one of the most notable approvals. It has shown significant efficacy in reducing symptoms and improving quality of life for patients with atopic dermatitis. Other biologics, such as Tralokinumab, which targets IL-13, have also been approved and are used in combination with topical corticosteroids. These treatments are similar to Nemolizumab, which targets the IL-31 receptor, as they all modulate the immune response to alleviate eczema symptoms.

What other types of research exist?

Promising novel alternatives to Nemolizumab for eczema patients include Dupilumab, which targets IL-4 and IL-13, and has shown favorable long-term safety and efficacy in children and adolescents. Additionally, Abrocitinib and Upadacitinib, both Janus kinase (JAK) inhibitors, have demonstrated efficacy in phase 3 trials for moderate-to-severe atopic dermatitis. Tralokinumab, targeting IL-13, is another promising option with positive results from phase 3 trials.

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Monoclonal Antibodies

Nemolizumab for Eczema

Phase 2

Recruiting

Research Sponsored by Galderma R&D

Eligibility Criteria Checklist

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

Must have

AD involvement >=10% of BSA at both screening and baseline visits

Chronic AD documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit

Must not have

Participants unwilling to refrain from using prohibited medications during the clinical trial.

Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nemolizumab, a medication designed to help children with moderate-to-severe eczema. Nemolizumab is a medication developed for treating skin diseases, including severe eczema. The drug works by blocking proteins that cause skin problems and itching. Researchers aim to see how well it works and if it is safe for these children.

Who is the study for?

This trial is for children aged 2-11 with moderate-to-severe atopic dermatitis (eczema) lasting over 6 months to a year, depending on age. They must have certain severity scores, affected body area coverage, and agree to use moisturizers and topical steroids as directed. Children under 10 kg or with chronic bronchitis, certain infections like hepatitis B/C or HIV, immunosuppression issues, or known allergies to immunoglobulin products cannot participate.

What is being tested?

The study tests Nemolizumab's effects on pediatric patients with severe eczema. It looks into how the drug moves inside the body (pharmacokinetics), its safety profile, and how effective it is in reducing eczema symptoms.

What are the potential side effects?

While specific side effects of Nemolizumab are not listed here, similar medications can cause reactions at injection sites, increased risk of infections due to immune system changes, headaches, nausea and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My skin condition affects more than 10% of my body.

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My child has had chronic eczema for the required time before screening.

Exclusion Criteria

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

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I am willing to stop taking certain medications for the trial.

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I might need extra help for my atopic dermatitis soon.

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I have chronic bronchitis.

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My body weight is under 10 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52

Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52

Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52

+15 more

Side effects data

From 2022 Phase 3 trial • 274 Patients • NCT04501679

Headache

Dermatitis atopic

Neurodermatitis

Pemphigoid

Dermatitis contact

Pneumonia

Supraventricular tachycardia

Pneumococcal sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Nemolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 2: Participants aged 2-6 yearsExperimental Treatment1 Intervention

Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Group II: Cohort 1: Participants aged 7-11 yearsExperimental Treatment1 Intervention

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Group III: Cohort 1.1: Participants aged 7-11 yearsExperimental Treatment1 Intervention

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nemolizumab

2022

Completed Phase 3

~2750

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, particularly systemic immunomodulatory treatments like Nemolizumab, work by targeting specific cytokines or receptors involved in the inflammatory pathways of the disease. Nemolizumab, for example, targets the IL-31 receptor, which plays a significant role in the itch-scratch cycle of eczema. Other treatments, such as Dupilumab, target the IL-4 and IL-13 pathways, reducing inflammation and improving skin barrier function. These mechanisms are important for patients to understand as they explain how these treatments can alleviate symptoms, reduce flare-ups, and enhance overall quality of life.

Systemic Immunomodulatory Treatments for Patients With Atopic Dermatitis: A Systematic Review and Network Meta-analysis.