Dupilumab for Prurigo Nodularis

Recruiting at 31 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dupilumab, a treatment for prurigo nodularis, a skin condition that causes very itchy, hard bumps. The study aims to assess the medication's safety and behavior in the body over several months. Participants must have had a prurigo nodularis diagnosis for at least three months and experience severe itching. The trial involves a series of visits over about 42 to 44 weeks, including treatment and follow-up periods. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that dupilumab is generally safe for people with prurigo nodularis, a skin condition that causes itchy bumps. Studies have found that the safety profile of dupilumab aligns with existing knowledge, with no new or unexpected side effects appearing in recent research.

In previous trials, dupilumab was considered safe for treating moderate-to-severe prurigo nodularis, with most participants not experiencing serious side effects. The fact that dupilumab is already approved for other conditions further supports its safety for prurigo nodularis.

While no treatment is without risk, current evidence suggests that dupilumab is generally safe for this use. For questions or concerns, consulting a healthcare provider can help determine if joining a clinical trial is the right choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prurigo nodularis?

Most treatments for prurigo nodularis focus on reducing inflammation and itching using topical steroids or antihistamines. But Dupilumab works differently, targeting a specific pathway in the immune system that contributes to the condition. Researchers are excited about this because it blocks the activity of proteins that drive inflammation, potentially offering relief for patients who don't respond well to standard treatments. Plus, since it's administered as a subcutaneous injection based on weight and age, it provides a tailored approach that could improve patient outcomes.

What evidence suggests that Dupilumab might be an effective treatment for Prurigo Nodularis?

Research has shown that dupilumab, the treatment under study in this trial, effectively treats prurigo nodularis, a skin condition causing itchy, hard bumps. Studies have found that patients using dupilumab experience significantly less itchiness and improved skin appearance compared to those not using it. Specifically, dupilumab reduces the number of skin bumps, improves doctor-assessed skin scores, and enhances overall quality of life for individuals with moderate to severe prurigo nodularis. These findings suggest that dupilumab is a promising treatment option for this condition. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. dupixenthcp.com dupixenthcp.com/prurigo-nodularis/efficacy

Prurigo Nodularis Find efficacy results and safety data in adult patients with prurigo nodularis (PN) using DUPIXENT® (dupilumab) as a treatment option.

2. nature.com nature.com/articles/s41591-023-02320-9

Dupilumab in patients with prurigo nodularis Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12262036/

Dupilumab treatment for prurigo nodularis: a retrospective ... Dupilumab effectively reduces the number of PN, improves IGA scores, alleviates pruritus, and enhances quality of life in patients with moderate to severe PN, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06087627

NCT06087627 | A Non-interventional Study to Describe the ... New initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666328724000683

Dupilumab improves pruritus and skin lesions in patients ... Phase 3 PRIME/PRIME2 trials independently demonstrated efficacy and an acceptable safety profile of dupilumab adults with moderate-to-severe prurigo nodularis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9895771/

Dupilumab for the treatment of prurigo nodularis The objective of this study was to systematically review dupilumab-related treatment outcomes in prurigo nodularis.