Nemolizumab for Prurigo Nodularis

Not currently recruiting at 159 trial locations

Overseen By Galderma Research & Development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Galderma R&D

Disqualifiers: Pregnancy, Breastfeeding, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 192 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety of nemolizumab for individuals with prurigo nodularis, a skin condition that causes itchy bumps. The goal is to assess the safety of nemolizumab over an extended period. It targets those who have already participated in earlier nemolizumab studies for this condition. If you previously participated in a nemolizumab study for prurigo nodularis and are interested in continued treatment, this trial might be suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to the potential availability of this treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants must refrain from using prohibited medications during the study.

Is there any evidence suggesting that nemolizumab is likely to be safe for humans?

Research has shown that nemolizumab is generally safe for people with prurigo nodularis (PN). In earlier studies, patients experienced clear and lasting improvements in symptoms such as itching and skin bumps. The safety profile of nemolizumab is favorable, with treatment-related side effects occurring in more than 1% of participants, but no serious new safety issues emerged. Overall, these studies suggest that nemolizumab is a safe option for those considering participation in a clinical trial for PN. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prurigo nodularis, which often include topical steroids or antihistamines, nemolizumab offers a novel approach by targeting the IL-31 receptor. This mechanism directly addresses the itch-scratch cycle at the root of the condition. Researchers are excited about nemolizumab because it has the potential to provide more effective relief from itching with a convenient dosing schedule of once every four weeks. This could significantly improve the quality of life for patients who struggle with chronic symptoms.

What evidence suggests that nemolizumab might be an effective treatment for prurigo nodularis?

Research has shown that nemolizumab, the investigational treatment in this trial, can effectively treat prurigo nodularis, a condition that causes itchy skin bumps. In clinical trials, more than one-third of adults using nemolizumab achieved clear or almost clear skin after 16 weeks. The treatment also significantly reduced itching and skin bumps, with these benefits lasting up to two years. Participants generally tolerated nemolizumab well, experiencing side effects similar to those of a placebo. This evidence suggests that nemolizumab could be a promising option for managing prurigo nodularis symptoms. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Female participants of childbearing potential must agree to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception

Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study

You have participated in a previous study for the same condition and meet specific timing requirements for enrollment in this study.

Exclusion Criteria

You have had problems with alcohol or drug abuse in the last 6 months.

Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nemolizumab every 4 weeks based on their weight

Up to 192 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nemolizumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Nemolizumab Experimental Treatment 1 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.

Nemolizumab is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Nemluvio for:

• Prurigo nodularis
• Atopic dermatitis

Approved in European Union as Nemluvio for:

• Atopic dermatitis
• Prurigo nodularis

Approved in Japan as Nemluvio for:

• Atopic dermatitis

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a phase 2 trial involving 70 patients with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced itch within 48 hours compared to placebo, demonstrating a 19.5% reduction in peak pruritus.

Patients treated with nemolizumab also experienced significant improvements in sleep disturbances by Day 4, with a 24.0% reduction in sleep disturbance scores, indicating its potential to enhance quality of life for those suffering from this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. Ständer, S., Yosipovitch, G., Lacour, JP., et al.[2022]

In a phase 2a trial involving 50 patients with prurigo nodularis, vixarelimab significantly reduced itch severity by 50.6% compared to 29.4% in the placebo group after 8 weeks, indicating its efficacy in managing this chronic skin condition.

Vixarelimab also led to clearer skin in 30.4% of patients, with no serious adverse events reported, suggesting it is a safe and effective treatment option for reducing both pruritus and skin nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of vixarelimab, a human monoclonal oncostatin M receptor β antibody, in moderate-to-severe prurigo nodularis: a randomised, double-blind, placebo-controlled, phase 2a study. Sofen, H., Bissonnette, R., Yosipovitch, G., et al.[2023]

In a phase 3 trial involving 274 adults with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced itch and improved skin condition compared to placebo, with 56.3% of patients experiencing a notable reduction in itch versus 20.9% in the placebo group.

Nemolizumab also led to significant improvements in sleep quality and overall skin assessment, with common side effects being mild, such as headaches and atopic dermatitis, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. Kwatra, SG., Yosipovitch, G., Legat, FJ., et al.[2023]

In a 12-week phase 2 trial involving 70 patients with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced pruritus by 53% compared to a 20% reduction in the placebo group, demonstrating its efficacy in alleviating severe itching.

While nemolizumab showed promising results in reducing symptoms, it was associated with gastrointestinal and musculoskeletal side effects, indicating the need for further studies to assess its long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. Ständer, S., Yosipovitch, G., Legat, FJ., et al.[2020]

In a 16-week phase 3 trial involving 215 Japanese patients with moderate-to-severe atopic dermatitis, nemolizumab significantly reduced pruritus (itchiness) compared to placebo, with a mean percent change in the visual-analogue scale (VAS) score of -42.8% versus -21.4%.

Nemolizumab also showed greater improvements in overall skin severity (EASI score) and quality of life (DLQI score) compared to placebo, although it had a higher incidence of injection-related reactions (8% vs 3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus. Kabashima, K., Matsumura, T., Komazaki, H., et al.[2020]

Nemolizumab, a monoclonal antibody targeting interleukin 31 receptor α, shows promise as a treatment for moderate to severe prurigo nodularis (PN), significantly reducing itch and skin lesions in patients who experienced a notable decrease in pruritus after treatment.

In a study of 38 patients, nemolizumab treatment was associated with downregulation of inflammatory and neural signaling pathways, as well as changes in tissue remodeling and epidermal differentiation, indicating its potential mechanism of action in alleviating symptoms of PN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Neuroimmune and Epithelial Dysregulation in Patients With Moderate to Severe Prurigo Nodularis Treated With Nemolizumab. Deng, J., Liao, V., Parthasarathy, V., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40205064/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1DqqIY7i9Icf9J_BIwh0PRg_lq4ZdpZVa2NCCBt_Z5SBUCUY-a&fc=20220524054013&ff=20250410052137&v=2.18.0.post9+e462414

Effectiveness and Safety of Nemolizumab in Patients with ...

Safety outcomes did not differ significantly between nemolizumab and placebo for adverse events, serious adverse events, or other specific ...

2.

nemluvio.com

nemluvio.com/prurigo-nodularis/about-nemluvio/nemluvio-results

NEMLUVIO® Clinical Trial Results for Prurigo Nodularis

More than one-third of adults using NEMLUVIO in clinical trials achieved clear or almost clear skin at Week 16 (38% vs 11% with placebo).

3.

galderma.com

galderma.com/news/icd-2025-new-data-nemluvio-prurigo-nodularis

ICD 2025: New data demonstrate Nemluvio®'s ...

The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions.

4.

ajmc.com

ajmc.com/view/nemolizumab-s-long-term-data-reinforce-efficacy-tolerability-in-prurigo-nodularis

Nemolizumab's Long-Term Data Reinforce Efficacy, ...

Nemolizumab significantly and safely improved itch and skin lesions for up to 2 years in patients with moderate to severe prurigo nodularis.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0365059625001527

Efficacy and safety of nemolizumab in prurigo nodularis

Statistical analysis usedR Studio 4.3.2. Results. Three trials, involving 630 patients, were included. Nemolizumab significantly reduced pruritus at week-4 (MD ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40112876/

Long-term (68 weeks) administration of nemolizumab and ...

Nemolizumab elicited continuous and durable improvements across multiple measures of pruritus, PN severity and QoL over 68 weeks of treatment, with no new ...

7.

nemluviohcp.com

nemluviohcp.com/prurigo-nodularis/clinical-results/safety

NEMLUVIO® Safety Profile in Prurigo Nodularis

NEMLUVIO offers a favorable safety profile. 1 TREATMENT-EMERGENT ADVERSE REACTIONS 1 Occurring in ≥1% of the NEMLUVIO group and greater than placebo.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04501666

NCT04501666 | Study to Assess the Efficacy and Safety of ...

The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age ...