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

Last updated: June 25, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Dermatitis, Atopic

Prurigo Nodularis

Treatment

Dupilumab

Clinical Study ID

NCT06293053
PKM17836
U1111-1287-7255
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants must be ≥6 months to <18 years of age, at the time of signing theinformed 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 bepresent 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 participantsaged ≥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

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-Diaryfor the duration of the study.

  • Contraceptive use by male and female participants should be consistent with localregulations regarding the methods of contraception for those participating inclinical studies.

Exclusion

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/orother skin conditions that may interfere with the PN diagnosis including but notlimited to the following: scabies, psoriasis, lymphomatoid papulosis, habitualpicking, 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 thescreening period.

NOTE: Participants may be rescreened after infection resolves.

  • Known or suspected immunodeficiency, including history of invasive opportunisticinfections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, andaspergillosis) despite infection resolution, or otherwise recurrent infections ofabnormal frequency or prolonged duration suggesting an immune compromised status, asjudged by the Investigator.

  • Severe concomitant illness(es) that, in the Investigator's judgment, would adverselyaffect the participant's participation in the study.

  • Planned or anticipated major surgical procedure during the participant'sparticipation in this clinical trial.

  • Participants who has taken biologic therapy/systemic immunosuppressant/immunomodulator within 4 weeks before the screening visit or 5 half-lives, whicheveris longer.

  • Current participation to any clinical trial of an investigational drug or device orparticipation within 3 months before the screening visit or 5 half-lives of theinvestigational compound, whichever is longer.

  • Participation in prior dupilumab clinical study or have been treated withcommercially available dupilumab.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase: 3
Study Start date:
May 15, 2024
Estimated Completion Date:
November 03, 2027

Connect with a study center

  • Mission Dermatology Center Site Number : 8400011

    Rancho Santa Margarita, California 92688
    United States

    Active - Recruiting

  • Mission Dermatology Center- Site Number : 8400011

    Rancho Santa Margarita, California 92688
    United States

    Active - Recruiting

  • Pediatric Center Of Excellence Site Number : 8400005

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Pediatric Center Of Excellence- Site Number : 8400005

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Life Clinical Trials - Coral Springs- Site Number : 8400018

    Coral Springs, Florida 33071
    United States

    Active - Recruiting

  • Life Clinical Trials- Site Number : 8400018

    Coral Springs, Florida 33071
    United States

    Active - Recruiting

  • Direct Helpers Research Center- Site Number : 8400015

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • USF Health - Dermatology and Cutaneous Surgery - Davis Blvd Location (Pediatric Dermatology) Site Number : 8400003

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • USF Health - Dermatology and Cutaneous Surgery - Davis Blvd Location (Pediatric Dermatology)- Site Number : 8400003

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • USF Health- Site Number : 8400003

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • MediSearch Clinical Trials (Dermatology) Site Number : 8400004

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • MediSearch Clinical Trials- Site Number : 8400004

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • AXIS Clinicals - Fargo- Site Number : 8400013

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Axis Clinicals Site Number : 8400013

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Axis Clinicals- Site Number : 8400013

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Vital Prospects Clinical Research Institute, P.C. Site Number : 8400002

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Dell Children's Medical Center- Site Number : 8400007

    Austin, Texas 78723
    United States

    Active - Recruiting

  • Driscoll Children's Hospital- Site Number : 8400017

    Corpus Christi, Texas 78411
    United States

    Active - Recruiting

  • 1960 Family Practice Site Number : 8400009

    Houston, Texas 77090
    United States

    Active - Recruiting

  • 1960 Family Practice- Site Number : 8400009

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Texas Dermatology and Laser Specialists- Site Number : 8400020

    San Antonio, Texas 78218
    United States

    Active - Recruiting

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