Nemolizumab for Eczema

No longer recruiting at 34 trial locations

Overseen By Galderma Research & Development

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Galderma R&D

Must be taking: Topical corticosteroids

Disqualifiers: Chronic bronchitis, Hepatitis, HIV, others

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

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: 4

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called nemolizumab, an experimental drug, to assess its effectiveness, safety, and movement through the body in children with moderate-to-severe eczema, a condition causing itchy, inflamed skin. Children aged 2 to 11 who have had eczema for a while and experience significant flare-ups might be suitable candidates. Participants will receive the treatment for up to a year, with researchers closely monitoring their eczema's response. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 trial. It's best to discuss your current medications with the trial team to see if they are allowed.

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

Research has shown that nemolizumab is well-tolerated in previous studies. In one study, patients using nemolizumab for up to 104 weeks experienced significant improvements in their eczema symptoms without major safety concerns. Another report indicated that long-term use of nemolizumab in children with eczema did not reveal any new safety issues, suggesting it is safe over extended periods. These findings support the idea that nemolizumab is generally safe for treating eczema, including in young children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nemolizumab is unique because, unlike other eczema treatments that mainly focus on reducing inflammation or moisturizing the skin, it specifically targets and blocks the activity of a protein called IL-31. IL-31 is known to play a crucial role in causing itchiness in eczema patients. Researchers are excited about nemolizumab because it has the potential to provide relief from itching, which is often the most distressing symptom of eczema, leading to better overall management of the condition.

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

Research has shown that nemolizumab effectively treats atopic dermatitis, also known as eczema. In one study, 44% of participants using nemolizumab with skin creams experienced at least a 75% improvement in their eczema. Another study found that nemolizumab improved skin condition, reduced itchiness, and enhanced sleep and quality of life over two years. Participants tolerated nemolizumab well, and it provided significant relief from eczema symptoms with long-term use. These findings suggest that nemolizumab can greatly benefit those with moderate-to-severe eczema. Participants in this trial will receive nemolizumab for 52 weeks, with different cohorts based on age groups. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have experienced severe pain during both the screening and baseline visits.

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

I agree to use a moisturizer and prescribed steroid cream as directed throughout the study.

Exclusion Criteria

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

I might need extra help for my atopic dermatitis soon.

Other protocol defined exclusion criteria could apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nemolizumab for 52 weeks

52 weeks

Visits at Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

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 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.

How Is the Trial Designed?

Group I: Cohort 2: Participants aged 2-6 years Experimental Treatment 1 Intervention

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

Group II: Cohort 1: Participants aged 7-11 year Experimental Treatment 1 Intervention

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

Group III: Cohort 1.1: Participants aged 7-11 years Experimental Treatment 1 Intervention

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

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 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, an anti-IL-31 receptor blocker, showed significant itch relief in patients with moderate-to-severe atopic dermatitis as early as Day 2, with a 68% response rate by week 16 compared to only 16% in the placebo group.

The treatment also led to rapid improvements in sleep disturbances and overall skin inflammation, with 50% of patients achieving a 75% reduction in Eczema Area and Severity Index (EASI) scores, demonstrating both efficacy and a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab is associated with a rapid improvement in atopic dermatitis signs and symptoms: subpopulation (EASI ≥ 16) analysis of randomized phase 2B study. Silverberg, JI., Pinter, A., Alavi, A., et al.[2022]

In a 16-week open-label study involving 20 adolescents aged 12-17 with moderate to severe atopic dermatitis, nemolizumab significantly improved skin rash, itch, and sleep disturbances, with reductions in EASI scores by 66.5% and PP-NRS by 43.2%.

The pharmacokinetics of nemolizumab in adolescents were similar to those observed in adults, indicating consistent safety and efficacy profiles, with mild to moderate adverse events reported in 33.3% of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. Sidbury, R., Alpizar, S., Laquer, V., et al.[2022]

In a 52-week extension study involving 191 patients, nemolizumab maintained significant improvements in pruritus and dermatitis scores, particularly in the 0.5 mg/kg Q4W group, demonstrating its long-term efficacy for treating moderate-to-severe atopic dermatitis.

The treatment was overall well tolerated, with 83% to 89% of patients experiencing at least one adverse event, but no new safety concerns were identified, indicating a favorable safety profile over the 64-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. Kabashima, K., Furue, M., Hanifin, JM., et al.[2019]

Nemolizumab, an anti-IL-31 receptor monoclonal antibody, has shown significant efficacy in reducing itching (pruritus) and to a lesser extent, skin inflammation (dermatitis) in patients with atopic dermatitis, based on multiple phase II and III studies.

The treatment has a rapid onset of action and a mild side effect profile, with severe adverse effects being rare, making it a promising option for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab for atopic dermatitis. Labib, A., Vander Does, A., Yosipovitch, G.[2022]

Nemolizumab is a novel biologic approved for treating itching associated with atopic dermatitis, showing significant efficacy in reducing pruritus and improving skin symptoms and quality of life over a 16-week period in patients aged 13 and older.

While effective, nemolizumab can cause worsening of atopic dermatitis and other side effects, necessitating careful monitoring and management of patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological profiles and clinical findings of nemolizumab as treatment for pruritus associated with atopic dermatitis]. Kaneda, N.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41081535/

Safety and efficacy of nemolizumab for atopic dermatitis up ... Conclusions: Continuous nemolizumab treatment was well-tolerated through W104 with clinically meaningful improvements in AD signs and symptoms ...

2. galderma.com galderma.com/news/rad-2025-nemluvio

RAD 2025: Long-term data on Nemluvio® (nemolizumab) ... Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.

3. nemluvio.com nemluvio.com/eczema/about-nemluvio/nemluvio-results

Eczema (Atopic Dermatitis) Clinical Trial Results 44% of those using NEMLUVIO + topicals saw an improvement of at least 75% or more in the severity of their eczema (atopic dermatitis) and the extent of their ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04921345

Study Details | NCT04921345 | Pharmacokinetics, Safety ... The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic ...

5. academic.oup.com academic.oup.com/bjd/article/193/1/56/8088394

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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39607831/

Long-term (68 weeks) administration of nemolizumab in ... Conclusions: These data confirm the safety of long-term nemolizumab for paediatric patients with AD, and demonstrate improvements in pruritus, ...