Nemolizumab for Eczema

Recruiting at30 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Galderma R&D

Must be taking: Topical corticosteroids

Disqualifiers: Chronic bronchitis, Hepatitis, HIV, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Nemolizumab for eczema?

Research shows that Nemolizumab, a drug that blocks a protein involved in itching and inflammation, improved itching, skin symptoms, and quality of life in people with moderate-to-severe eczema who didn't respond well to other treatments. Studies found that it helped reduce itching and skin issues over several weeks, leading to better sleep and overall well-being. ^{1 2 3 4 5}

Is Nemolizumab safe for humans?

Nemolizumab has been studied in people with atopic dermatitis and generally shows mild and temporary side effects like worsening of dermatitis, common cold symptoms, and upper respiratory infections. Serious side effects are rare, but can include worsening of dermatitis and asthma. ^{1 2 3 4 6}

How is the drug Nemolizumab different from other eczema treatments?

Nemolizumab is unique because it targets the interleukin-31 receptor, which is involved in the itching and inflammation of eczema, and is administered as an injection under the skin every four weeks. It works quickly to reduce itching and improve skin symptoms, making it a promising option for those who haven't found relief with other treatments. ^{1 2 3 5 6}

Research Team

Eligibility Criteria

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.

I have chronic bronchitis.

Trial Timeline

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

Treatment Details

Interventions

• Nemolizumab (Monoclonal Antibodies)

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.

Participant Groups

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 years 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 Japan for the following indications:

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

Findings from Research

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus. [2020]

3. Japan pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, Efficacy, and Biomarker Profiles During Nemolizumab Treatment of Atopic Dermatitis in Adolescents. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Nemolizumab for atopic dermatitis. [2022]