What side effects are associated with this type of intervention?

Common treatments for Prurigo Nodularis that target the IL-31 receptor, like Nemolizumab, aim to reduce itching and inflammation. Known side effects of similar treatments, such as dupilumab, include injection site reactions, conjunctivitis, and nasopharyngitis. Other treatments like immunosuppressants (e.g., methotrexate, cyclosporine) can cause liver toxicity, kidney dysfunction, and increased risk of infections. It is important to monitor these side effects closely under medical supervision.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Prurigo Nodularis that target the IL-31 receptor like Nemolizumab. However, treatments for similar conditions, such as atopic dermatitis, include drugs like Dupilumab, which targets the IL-4 and IL-13 pathways to reduce inflammation and itching. These treatments provide a basis for understanding the potential efficacy of Nemolizumab in managing Prurigo Nodularis by targeting inflammatory pathways.

What other types of research exist?

Promising novel alternatives to Nemolizumab for Prurigo Nodularis patients include: 1) Dupilumab, which targets the IL-4 and IL-13 pathways and has shown efficacy in atopic dermatitis, a condition with similar inflammatory profiles. 2) Abrocitinib, a JAK inhibitor, which has demonstrated significant reduction in pruritus in atopic dermatitis. 3) Upadacitinib, another JAK inhibitor, which has shown promising results in reducing inflammation and itching in atopic dermatitis. These alternatives are being explored for their potential benefits in treating PN.

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Monoclonal Antibodies

Nemolizumab for Prurigo Nodularis

Phase 3

Waitlist Available

Research Sponsored by Galderma R&D

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Participants unwilling to refrain from using prohibited medications during the clinical study

Body weight < 30 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 192 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety of nemolizumab, a medication for people with prurigo nodularis. Prurigo nodularis is a skin condition that causes itchy, hard lumps. Nemolizumab aims to reduce itching and swelling by blocking certain signals in the body.

Who is the study for?

This trial is for individuals with Prurigo Nodularis who've been in previous nemolizumab studies. They must be able to follow the study's procedures, including weekly electronic check-ins. Women of childbearing age should avoid pregnancy or use contraception during and for 12 weeks post-trial.

What is being tested?

The focus of this study is on the long-term safety of a drug called nemolizumab (CD14152) for those suffering from Prurigo Nodularis, a skin condition that causes itchy nodules.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to nemolizumab as part of assessing its long-term safety profile.

Eligibility Criteria

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 study.

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My body weight is less than 30 kg.

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I am planning to undergo a major surgery during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 192 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 192 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 192 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Adverse Events (AEs) by Severity

Secondary study objectives

Absolute Change from Baseline in AP NRS up to Week 52

Absolute Change from Baseline in PP NRS up to Week 184

Absolute Change from Baseline in SD NRS up to Week 184

+19 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.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: NemolizumabExperimental Treatment1 Intervention

Participants weighing less than (\<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (\>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nemolizumab

2022

Completed Phase 3

~2750

0 / 3Eligibility 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

Nemolizumab works by inhibiting the IL-31 receptor, which plays a crucial role in the sensation of itch and the inflammatory response in Prurigo Nodularis (PN). By blocking this receptor, nemolizumab reduces both itching and inflammation, which are primary symptoms of PN. Other common treatments for PN include topical corticosteroids, which reduce inflammation by suppressing the immune response, and antihistamines, which block histamine receptors to alleviate itching. Understanding these mechanisms is important for PN patients as it helps them and their healthcare providers choose treatments that specifically target the underlying causes of their symptoms, leading to more effective management of the condition.