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

NCT06293053 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: PKM17836U1111-1287-7255
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 14

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

Outcome Measures

Primary Outcomes (1)

• Concentration of dupilumab in serum

  Concentration of dupilumab in serum over time

  Day 1 to Week 40

Secondary Outcomes (2)

• Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)

  Date of signed ICF (2-4 weeks before Day 1) to Week 40

• Incidence of anti-drug antibodies (ADA) to dupilumab over time

  Day 1 to Week 40

Study Arms (1)

Dupilumab

EXPERIMENTAL

Administered subcutaneously (SC) based on weight and age

Drug: Dupilumab

Interventions

Dupilumab DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Also known as: SAR231893, Dupixent

Dupilumab

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (14)

Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021

Palo Alto, California, 94304, United States

RECRUITING

Mission Dermatology Center- Site Number : 8400011

Rancho Santa Margarita, California, 92688, United States

RECRUITING

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

Coral Gables, Florida, 33146, United States

RECRUITING

Life Clinical Trials - Coral Springs- Site Number : 8400018

Coral Springs, Florida, 33071, United States

RECRUITING

Direct Helpers Research Center- Site Number : 8400015

Hialeah, Florida, 33012, United States

RECRUITING

SunCoast Skin Solutions - Lutz- Site Number : 8400008

Lutz, Florida, 33558, United States

RECRUITING

USF Health- Site Number : 8400003

Tampa, Florida, 33606, United States

RECRUITING

Tareen Dermatology - Eagan- Site Number : 8400022

Eagan, Minnesota, 55123, United States

RECRUITING

MediSearch Clinical Trials- Site Number : 8400004

Saint Joseph, Missouri, 64506, United States

RECRUITING

AXIS Clinicals - Fargo- Site Number : 8400013

Fargo, North Dakota, 58103, United States

RECRUITING

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

Tulsa, Oklahoma, 74136, United States

RECRUITING

Dell Children's Medical Center- Site Number : 8400007

Austin, Texas, 78723, United States

RECRUITING

Driscoll Children's Hospital- Site Number : 8400017

Corpus Christi, Texas, 78411, United States

RECRUITING

Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020

San Antonio, Texas, 78218, United States

RECRUITING

Related Links

• PKM17836 Plain Language Results Summary

MeSH Terms

Interventions

dupilumab

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): November 3, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (14)