Nemolizumab for Eczema

Recruiting at 350 trial locations

Overseen By Research & Development

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Galderma R&D

Must not be taking: Antibiotics, Antivirals, Antifungals

Disqualifiers: Pregnancy, Low body weight, 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: 200 weeks

1700 Participants Needed

Trial Summary

What is the purpose of this trial?

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a cutaneous infection or are taking antibiotics, antivirals, antiparasitics, or antifungals, you may need to wait until the infection is resolved before participating.

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, helps reduce itching and improve skin condition in people with moderate-to-severe eczema when other treatments don't work well. Studies found that it also improves sleep and quality of life for patients. ^{1 2 3 4 5}

Is Nemolizumab safe for humans?

Nemolizumab has been studied in people with atopic dermatitis, and most side effects were mild and temporary, like worsening of dermatitis, common cold symptoms, and skin infections. Serious side effects were rare, but included worsening of dermatitis and asthma. Overall, it shows a mild side effect profile and is considered generally safe in clinical trials. ^{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 4 5 6}

Eligibility Criteria

This trial is for individuals with moderate-to-severe atopic dermatitis who have previously participated in a nemolizumab study and may benefit from further treatment. Women of childbearing age must commit to abstinence or approved contraception during the study and for 12 weeks after. Exclusions include those with adverse reactions to previous nemolizumab use, current infections, recent COVID-19 infection, pregnancy, breastfeeding, or planning pregnancy.

Inclusion Criteria

You have previously participated in a study for a medication called nemolizumab for atopic dermatitis and may benefit from participating in this study.

I agree to avoid pregnancy during and for 12 weeks after the study by being abstinent or using birth control.

I agree to avoid pregnancy during the study and for 12 weeks after the last dose.

Exclusion Criteria

You have had a severe allergic reaction to a medication made from blood or genetically engineered proteins, like monoclonal antibodies.

My body weight is less than 30 kg.

I haven't had any skin infections, needed antibiotics, or had COVID-19 in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nemolizumab via subcutaneous injection

200 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Nemolizumab

Trial Overview The trial is assessing the long-term safety and effectiveness of Nemolizumab in treating moderate-to-severe atopic dermatitis (eczema). It's designed for participants who've been part of prior studies on this medication to continue observing its impacts over an extended period.

Participant Groups

Group I: Nemolizumab Experimental Treatment 1 Intervention

Nemolizumab administered via subcutaneous injection

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

Findings from Research

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]

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 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 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. Japan pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

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

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

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]