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A Two-year, Phase 4, Open-label, Single-arm Treatment Study to Evaluate the Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants (≥6 to <15 Years of Age) With Moderate-to-severe Atopic Dermatitis
This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and \<15 years at study entry) with moderate-to-severe AD. All eligible participants with AD will be treated with Dupixent® for 104 weeks according to locally approved Dupixent® product label (in country/region where the study is conducted). After the 104-week treatment phase and the last assessment at the End of Treatment (EoT), participants will be followed-up for 4 weeks and an End-of-Study (EoS) visit by telephone at 4 weeks after the EoT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period). The study population will include approximately 48 pediatric participants with AD for long-term treatment with dupilumab: * Treatment cohort 1 - newly recruited participants with AD (aged ≥6 to \<12 years at study entry) * Treatment cohort 2 - any former PELISTAD participants (from the previous 16-week treatment study \[PELISTAD/LPS16764\] who consent to participate in this long-term study; aged ≥6 to \<15 years at entry to this study)
Study duration for each participant will be approximately 112 weeks, including: * Screening period: Up to 4 weeks (Day -28 to Day -1) from signing the informed consent. * Open-label dupilumab treatment period: 104 weeks (from Day 1/Week 0 to Week 104). * Follow-up period: 4 weeks (safety follow-up phone visit at 4 weeks after the EoT visit).
Age
6 - 14 years
Sex
ALL
Healthy Volunteers
No
National Jewish Health Medical Center- Site Number : 8400001
Denver, Colorado, United States
SSM Health Saint Louis University Hospital- Site Number : 8400006
St Louis, Missouri, United States
NYU Langone Medical Center- Site Number : 8400004
New York, New York, United States
Investigational Site Number : 8260001
Sheffield, United Kingdom
Start Date
February 22, 2024
Primary Completion Date
May 29, 2026
Completion Date
August 7, 2026
Last Updated
May 15, 2025
48
ESTIMATED participants
dupilumab
DRUG
Lead Sponsor
Sanofi
Collaborators
NCT05769777
NCT03687359
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03992417