Recruiting
Phase 3

Dupilumab

Sponsor:

Sanofi

Code:

NCT06293053

Conditions

Prurigo Nodularis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Study Details

Brief 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.

Conditions

Prurigo Nodularis

Study ID

NCT06293053

Start date

May 15, 2024

Status verified date

Oct, 2026

Completion date

Nov 3, 2027

Anticipated

Primary completion date

Oct 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dupilumab

Administered subcutaneously (SC) based on weight and age

Interventions

Dupilumab

Pharmaceutical form: Injection solution

Route of administration: Subcutaneous

Primary outcome measure

  • Concentration of dupilumab in serum [ Time Frame: Day 1 to Week 40 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Stanford University Medical Center (CTRU)- Site Number : 8400021

Recruiting

Palo Alto, California, United States, 94304

Mission Dermatology Center- Site Number : 8400011

Recruiting

Rancho Santa Margarita, California, United States, 92688

Golden State Dermatology - Walnut Creek - Ygnacio Valley Road- Site Number : 8400023

Recruiting

Walnut Creek, California, United States, 94598

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

Recruiting

Coral Gables, Florida, United States, 33146

Life Clinical Trials - Coral Springs- Site Number : 8400018

Recruiting

Coral Springs, Florida, United States, 33071

Direct Helpers Research Center- Site Number : 8400015

Recruiting

Hialeah, Florida, United States, 33012

SunCoast Skin Solutions - Lutz- Site Number : 8400008

Recruiting

Lutz, Florida, United States, 33558

USF Health- Site Number : 8400003

Recruiting

Tampa, Florida, United States, 33606

Tareen Dermatology - Eagan- Site Number : 8400022

Recruiting

Eagan, Minnesota, United States, 55123

MediSearch Clinical Trials- Site Number : 8400004

Recruiting

Saint Joseph, Missouri, United States, 64506

AXIS Clinicals - Fargo- Site Number : 8400013

Recruiting

Fargo, North Dakota, United States, 58103

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

Recruiting

Tulsa, Oklahoma, United States, 74136

Dell Children's Medical Center- Site Number : 8400007

Recruiting

Austin, Texas, United States, 78723

Driscoll Children's Hospital- Site Number : 8400017

Recruiting

Corpus Christi, Texas, United States, 78411

Oakwell Clinical Research- Site Number : 8400020

Recruiting

San Antonio, Texas, United States, 78218

More Information

Sponsor

Sanofi

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.