RecruitingPhase 3NCT06293053

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

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


Sponsor

Sanofi

Enrollment

18 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dupilumab for people with prurigo nodularis. The study is currently recruiting participants at 14 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab

Pharmaceutical form: Injection solution Route of administration: Subcutaneous


Locations(14)

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

Palo Alto, California, United States

Mission Dermatology Center- Site Number : 8400011

Rancho Santa Margarita, California, United States

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

Coral Gables, Florida, United States

Life Clinical Trials - Coral Springs- Site Number : 8400018

Coral Springs, Florida, United States

Direct Helpers Research Center- Site Number : 8400015

Hialeah, Florida, United States

SunCoast Skin Solutions - Lutz- Site Number : 8400008

Lutz, Florida, United States

USF Health- Site Number : 8400003

Tampa, Florida, United States

Tareen Dermatology - Eagan- Site Number : 8400022

Eagan, Minnesota, United States

MediSearch Clinical Trials- Site Number : 8400004

Saint Joseph, Missouri, United States

AXIS Clinicals - Fargo- Site Number : 8400013

Fargo, North Dakota, United States

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

Tulsa, Oklahoma, United States

Dell Children's Medical Center- Site Number : 8400007

Austin, Texas, United States

Driscoll Children's Hospital- Site Number : 8400017

Corpus Christi, Texas, United States

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

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06293053


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