Nemolizumab for Eczema

Not currently recruiting at 398 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called nemolizumab for individuals with moderate-to-severe eczema, a condition causing itchy and inflamed skin. The goal is to assess its long-term safety and effectiveness. Participants must have taken part in a previous nemolizumab study for eczema and should not have serious infections or allergies to similar treatments. Those who have struggled with intense eczema and experienced some relief from nemolizumab before might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the validation of a promising treatment.

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.

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 atopic dermatitis, a type of eczema. In past studies, ongoing treatment with nemolizumab led to noticeable improvements in eczema symptoms and was well-received by patients.

Some patients experienced side effects, but these were uncommon. For instance, more than 1% of patients taking nemolizumab reported side effects, which is considered a low rate. Long-term data did not reveal any new safety issues.

Nemolizumab is also approved for other conditions, indicating it has undergone safety reviews. However, its safety and effectiveness for children under 12 with eczema remain unknown. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nemolizumab is unique because it targets the IL-31 receptor, which plays a key role in the itch and inflammation associated with eczema. Most treatments for eczema, like topical corticosteroids or calcineurin inhibitors, focus on reducing inflammation but don't directly address the itch pathway. Administered via subcutaneous injection, Nemolizumab offers a novel approach by blocking the action of IL-31, potentially providing more effective relief from itching with fewer topical side effects. Researchers are excited because this could mean faster, more targeted relief for patients who struggle with chronic eczema symptoms.

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

Research shows that nemolizumab can help treat moderate-to-severe eczema, also known as atopic dermatitis. In earlier studies, 44% of patients who used nemolizumab with skin creams improved their eczema symptoms by at least 75%, experiencing less redness, swelling, and itching. Long-term use of nemolizumab led to ongoing improvements in skin condition, itchiness, sleep, and overall quality of life for up to two years. Some people noticed significant improvements as soon as 48 hours after starting treatment. Overall, nemolizumab provides meaningful relief for many people with eczema. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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

Eczema (Atopic Dermatitis) Clinical Trial Results - Nemluvio 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 ...

3. 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.

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. nemluviohcp.com nemluviohcp.com/atopic-dermatitis

NEMLUVIO® (nemolizumab-ilto) for Atopic Dermatitis Significant improvement was achieved at 48 hours (9% with NEMLUVIO + TCS/TCI vs 3% with placebo + TCS/TCI, P≤0.001).1,2. Data shown from ARCADIA 1 full ...

6. nemluviohcp.com nemluviohcp.com/atopic-dermatitis/clinical-results/safety

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

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761391s000lbl.pdf

FULL PRESCRIBING INFORMATION - accessdata.fda.gov Of the 1192 subjects with atopic dermatitis exposed to NEMLUVIO in the primary safety population, 72 (6.0%) subjects were 65 years of age or older. The long ...

8. nemluvio.com nemluvio.com/

NEMLUVIO® for Prurigo Nodularis and Atopic Dermatitis It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age. to treat adults with prurigo nodularis. It is ...