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Investigating Dupilumab for Children with Prurigo Nodularis

A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

Phase 3 Interventional Sanofi · NCT06293053

This study is testing if Dupilumab can help children with prurigo nodularis feel better and stay safe while using the medication.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment18 (estimated)
Ages6 Months to 17 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations14 sites (Palo Alto, California and 13 other locations)
Trial IDNCT06293053 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, open-label study aims to evaluate the pharmacokinetics and safety of Dupilumab in participants aged 6 months to under 18 years with prurigo nodularis. The study consists of a screening period of 2 to 4 weeks, followed by a 24-week treatment period, and a 16-week post-intervention follow-up. Participants will have a total of 6 planned study visits throughout the approximately 42 to 44 weeks of the study. The primary focus is on assessing the drug's effectiveness in managing symptoms and its safety profile in this pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 months to less than 18 years with a clinical diagnosis of prurigo nodularis and significant itch severity.

Not a fit: Patients who do not have prurigo nodularis or those with milder forms of the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for children suffering from prurigo nodularis, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using Dupilumab for similar conditions, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must be ≥6 months to \<18 years of age, at the time of signing the informed consent.
* A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline.
* On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to \<18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to \<6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1.

NOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.

* Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study.
* Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.

NOTE: Participants may be rescreened after infection resolves.

* 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.
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
* Planned or anticipated major surgical procedure during the participant's participation in this clinical trial.
* Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer.
* Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer.
* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

Where this trial is running

Palo Alto, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prurigo Nodularis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.