Nemolizumab for Prurigo Nodularis

Recruiting at 144 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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the safety of nemolizumab, a medication for people with prurigo nodularis. Prurigo nodularis is a skin condition that causes itchy, hard lumps. Nemolizumab aims to reduce itching and swelling by blocking certain signals in the body.

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.

What data supports the effectiveness of the drug Nemolizumab for treating prurigo nodularis?

Research shows that Nemolizumab, a drug that blocks a specific protein involved in causing itch, has been effective in reducing itch and improving sleep in patients with prurigo nodularis, a skin condition with itchy nodules. ^{1 2 3 4 5}

How is the drug Nemolizumab different from other treatments for prurigo nodularis?

Nemolizumab is unique because it is a monoclonal antibody that specifically targets the interleukin-31 receptor, which plays a key role in causing the intense itching and skin lesions in prurigo nodularis. This makes it a novel approach compared to other treatments that may not directly target this pathway. ^{1 2 3 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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 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]

References

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

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. [2020]

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

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. [2023]

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

Modulation of Neuroimmune and Epithelial Dysregulation in Patients With Moderate to Severe Prurigo Nodularis Treated With Nemolizumab. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. [2022]

5. England 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. [2023]

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

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Nemolizumab: First Approval. [2022]