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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Prurigo Nodularis
Intervention / Treatment

-

Contacts and Locations

Rancho Santa Margarita

Mission Dermatology Center- Site Number : 8400011, Rancho Santa Margarita, California, United States, 92688

Coral Gables

Pediatric Center Of Excellence- Site Number : 8400005, Coral Gables, Florida, United States, 33146

Tampa

USF Health - Dermatology and Cutaneous Surgery - Davis Blvd Location (Pediatric Dermatology)- Site Number : 8400003, Tampa, Florida, United States, 33606

Saint Joseph

MediSearch Clinical Trials- Site Number : 8400004, Saint Joseph, Missouri, United States, 64506

Fargo

Axis Clinicals- Site Number : 8400013, Fargo, North Dakota, United States, 58103

Tulsa

Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002, Tulsa, Oklahoma, United States, 74136

Houston

1960 Family Practice- Site Number : 8400009, Houston, Texas, United States, 77090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

6 Months to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2027-11-03