Dupilumab for Prurigo Nodularis

Recruiting at 20 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Atopic dermatitis, Infections, Immunodeficiency, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking biologic therapy or systemic immunosuppressants at least 4 weeks before the screening visit. If you are on these medications, you will need to stop them before joining the study.

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

Dupilumab has been shown to reduce itching and the number of skin lesions in prurigo nodularis, as demonstrated in two randomized controlled trials. Additionally, case studies and literature reviews indicate that patients with severe prurigo nodularis experienced significant improvement with Dupilumab, and it is generally well-tolerated. ^{1 2 3 4 5}

Is dupilumab safe for treating prurigo nodularis?

Dupilumab has been generally well-tolerated in studies for prurigo nodularis, with some patients experiencing mild side effects like dry eyes. It has shown good safety in clinical trials for other conditions like atopic dermatitis. ^{1 2 3 5 6}

How does the drug Dupilumab differ from other treatments for prurigo nodularis?

Dupilumab is unique because it is the first approved therapy specifically for prurigo nodularis, working by blocking certain proteins (IL-4 and IL-13) that cause inflammation, which helps reduce itching and skin lesions. It is administered as an injection under the skin and has shown good safety and effectiveness in clinical trials, unlike other treatments that often have severe side effects. ^{1 3 5 6 7}

What is the purpose of this trial?

This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks. * Treatment period: 24 weeks. * Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods). The total number of planned study visits for each participant will be 6.

Eligibility Criteria

This clinical trial is for children and teenagers from 6 months to under 18 years old with Prurigo Nodularis, a skin condition causing itchy lumps. They must have been diagnosed at least 3 months prior, have an itch intensity score of ≥7, and lesions on multiple body areas. Participants need to be able to use an e-Diary daily.

Inclusion Criteria

Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study

My worst itch score has been 7 or more in the past week.

Exclusion Criteria

I am expecting to undergo a major surgery during the trial.

I have not needed antibiotics, antivirals, or antifungals for an infection in the last 2 weeks.

Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 to 4 weeks

Treatment

Participants receive dupilumab administered subcutaneously based on weight and age for 24 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Dupilumab

Trial Overview The study tests Dupilumab's effects on young patients with Prurigo Nodularis over approximately one year. It includes a screening period, a treatment phase lasting six months where the drug is given, followed by four months of observation without treatment.

Participant Groups

Group I: Dupilumab Experimental Treatment 1 Intervention

Administered subcutaneously (SC) based on weight and age

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

Dupilumab, an antibody that targets interleukin-4 and interleukin-13 pathways, showed good to excellent responses in three patients with severe prurigo nodularis after being treated off-label, indicating its potential efficacy for this condition.

The treatment was generally well-tolerated, with only one patient experiencing dry eyes, suggesting a favorable safety profile; however, further research with larger controlled trials is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for prurigo nodularis: Case series and review of the literature. Holm, JG., Agner, T., Sand, C., et al.[2021]

Dupilumab is an effective treatment for prurigo nodularis (PN), with 82.22% of patients experiencing at least a 50% reduction in itch severity after treatment, and 48.88% achieving complete resolution after an average of 19.28 weeks.

Patients with atopic dermatitis-related PN experienced a delayed response to dupilumab, requiring longer treatment times for relief compared to those without atopic dermatitis, highlighting the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. Husein-ElAhmed, H., Steinhoff, M.[2022]

Dupilumab (Dupixent) is an approved treatment for prurigo nodularis, a rare and itchy skin condition, highlighting its efficacy in managing this specific disease.

Patients need to be educated on the proper subcutaneous administration of Dupilumab using a prefilled syringe, as well as safe disposal of the used syringe to ensure safety and effectiveness in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Dupilumab Indication for Rare Skin Disease. Aschenbrenner, DS.[2023]

Prurigo nodularis (PN) is a chronic condition with no FDA-approved treatments, characterized by severe itching and skin nodules, and current therapies often have significant side effects.

Dupilumab, a monoclonal antibody that targets interleukin-4 and interleukin-13 pathways, shows promise as a safe and effective treatment for PN, based on emerging positive data in the literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab as promising treatment for prurigo nodularis: current evidences. Toffoli, L., Farinazzo, E., Zelin, E., et al.[2022]

Dupilumab, a monoclonal antibody that blocks IL-4 and IL-13 signaling, has been approved as the first effective treatment for prurigo nodularis (PN), a chronic inflammatory skin condition characterized by itchy nodules.

Clinical trials demonstrated that dupilumab significantly reduces both itching and the number of skin lesions in patients with PN, marking a potential shift in treatment strategies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the Treatment of Prurigo Nodularis. Alkhaleefa, A., Woo, TE., Parsons, L.[2023]

In a study involving 45 Chinese patients with prurigo nodularis, dupilumab treatment led to significant improvements in itching and skin lesions within just 2 weeks, with all evaluated scores showing marked enhancement by the 16-week mark.

The treatment was well-tolerated, with no adverse events reported, highlighting dupilumab's safety and efficacy as a promising option for managing prurigo nodularis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of dupilumab in the management of refractory prurigo nodularis in 45 Chinese patients: A real-life observational study. Fang, HY., Lian, CH.[2023]

Dupilumab, a monoclonal antibody that inhibits the Th2 signaling pathway, is used to treat atopic dermatitis but can lead to the development of psoriasis in some patients, as seen in a case study of a 40-year-old man.

In this case, the abrupt discontinuation of oral steroid therapy alongside dupilumab treatment was identified as potential triggers for the onset of psoriasis, highlighting the need for careful management when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psoriasis in dupilumab-treated atopic dermatitis]. Senner, S., Eicher, L., Aszodi, N., et al.[2020]

References

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

Dupilumab for prurigo nodularis: Case series and review of the literature. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. [2022]

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

New Dupilumab Indication for Rare Skin Disease. [2023]

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

Dupilumab as promising treatment for prurigo nodularis: current evidences. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Dupilumab for the Treatment of Prurigo Nodularis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of dupilumab in the management of refractory prurigo nodularis in 45 Chinese patients: A real-life observational study. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Psoriasis in dupilumab-treated atopic dermatitis]. [2020]