Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Months and 17 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dupilumab
Administered subcutaneously (SC) based on weight and age
  • Drug: Dupilumab
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
    Other names:
    • SAR231893
    • Dupixent

Recruiting Locations

Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021
Palo Alto 5380748, California 5332921 94304

Mission Dermatology Center- Site Number : 8400011
Rancho Santa Margarita 5386082, California 5332921 92688

Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
Coral Gables 4151871, Florida 4155751 33146

Life Clinical Trials - Coral Springs- Site Number : 8400018
Coral Springs 4151909, Florida 4155751 33071

Direct Helpers Research Center- Site Number : 8400015
Hialeah 4158476, Florida 4155751 33012

SunCoast Skin Solutions - Lutz- Site Number : 8400008
Lutz 4163033, Florida 4155751 33558

USF Health- Site Number : 8400003
Tampa 4174757, Florida 4155751 33606

Tareen Dermatology - Eagan- Site Number : 8400022
Eagan 5024825, Minnesota 5037779 55123

MediSearch Clinical Trials- Site Number : 8400004
Saint Joseph 4407010, Missouri 4398678 64506

AXIS Clinicals - Fargo- Site Number : 8400013
Fargo 5059163, North Dakota 5690763 58103

Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002
Tulsa 4553433, Oklahoma 4544379 74136

Dell Children's Medical Center- Site Number : 8400007
Austin 4671654, Texas 4736286 78723

Driscoll Children's Hospital- Site Number : 8400017
Corpus Christi 4683416, Texas 4736286 78411

Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020
San Antonio 4726206, Texas 4736286 78218

More Details

NCT ID
NCT06293053
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.