A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age 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

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.

Study Overview

• Status: Recruiting
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: Dupilumab

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: contact-us@sanofi.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021
    • Rancho Santa Margarita, California, United States, 92688
      • Recruiting
      • Mission Dermatology Center- Site Number : 8400011
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
    • Coral Springs, Florida, United States, 33071
      • Recruiting
      • Life Clinical Trials - Coral Springs- Site Number : 8400018
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • Direct Helpers Research Center- Site Number : 8400015
    • Lutz, Florida, United States, 33558
      • Recruiting
      • SunCoast Skin Solutions - Lutz- Site Number : 8400008
    • Tampa, Florida, United States, 33606
      • Recruiting
      • USF Health- Site Number : 8400003
  • Minnesota
    • Eagan, Minnesota, United States, 55123
      • Recruiting
      • Tareen Dermatology - Eagan- Site Number : 8400022
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Recruiting
      • MediSearch Clinical Trials- Site Number : 8400004
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Recruiting
      • AXIS Clinicals - Fargo- Site Number : 8400013
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Children's Medical Center- Site Number : 8400007
    • Corpus Christi, Texas, United States, 78411
      • Recruiting
      • Driscoll Children's Hospital- Site Number : 8400017
    • San Antonio, Texas, United States, 78218
      • Recruiting
      • Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab; Administered subcutaneously (SC) based on weight and age	Drug: Dupilumab; Pharmaceutical form: Injection solution Route of administration: Subcutaneous; Other Names: Dupixent; SAR231893

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of dupilumab in serum	Concentration of dupilumab in serum over time	Day 1 to Week 40

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)	Date of signed ICF (2-4 weeks before Day 1) to Week 40
Incidence of anti-drug antibodies (ADA) to dupilumab over time	Day 1 to Week 40

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• PKM17836 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): November 3, 2027

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis; dupilumab
• Other Study ID Numbers: PKM17836; U1111-1287-7255 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No