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Recruiting Phase 3

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

NCT06293053 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2024-05-15
Last updated
2026-10-13

Condition(s) studied

Prurigo Nodularis

Investigational drug(s) / intervention(s)

Dupilumab →

Dupilumab: Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Study summary

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

Sex
ALL
Min age
6 Months
Max age
17 Years
Healthy volunteers
No
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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcome measure(s)

  • Concentration of dupilumab in serum — Day 1 to Week 40
    Concentration of dupilumab in serum over time

Trial sites (15)

FacilityCityRegionStatus
Stanford University Medical Center (CTRU)- Site Number : 8400021 Palo Alto California Recruiting
Mission Dermatology Center- Site Number : 8400011 Rancho Santa Margarita California Recruiting
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road- Site Number : 8400023 Walnut Creek California Recruiting
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005 Coral Gables Florida Recruiting
Life Clinical Trials - Coral Springs- Site Number : 8400018 Coral Springs Florida Recruiting
Direct Helpers Research Center- Site Number : 8400015 Hialeah Florida Recruiting
SunCoast Skin Solutions - Lutz- Site Number : 8400008 Lutz Florida Recruiting
USF Health- Site Number : 8400003 Tampa Florida Recruiting
Tareen Dermatology - Eagan- Site Number : 8400022 Eagan Minnesota Recruiting
MediSearch Clinical Trials- Site Number : 8400004 Saint Joseph Missouri Recruiting
AXIS Clinicals - Fargo- Site Number : 8400013 Fargo North Dakota Recruiting
Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002 Tulsa Oklahoma Recruiting
Dell Children's Medical Center- Site Number : 8400007 Austin Texas Recruiting
Driscoll Children's Hospital- Site Number : 8400017 Corpus Christi Texas Recruiting
Oakwell Clinical Research- Site Number : 8400020 San Antonio Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06293053 on ClinicalTrials.gov ↗ ← All trials in the USA