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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by Sanofi
Sponsor
Sanofi
Information Provided by (Responsible Party)
Sanofi
Clinicaltrials.gov Identifier
NCT06293053
Other Study ID Numbers:
PKM17836
First Submitted
February 26, 2024
First Posted
March 4, 2024
Last Update Posted
January 14, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Prurigo Nodularis
Drug: Dupilumab

Study Design

Study TypeInterventional
Actual Enrollment18 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Study Start DateMay 14, 2024
Actual Primary Completion Date1yr 5mos from now
Actual Study Completion Date1yr 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Dupilumab
Administered subcutaneously (SC) based on weight and age
Drug: Dupilumab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Outcome Measures

Primary Outcome Measures
  1. Concentration of dupilumab in serum
    Concentration of dupilumab in serum over time
Secondary Outcome Measures
  1. Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
  2. Incidence of anti-drug antibodies (ADA) to dupilumab over time

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

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