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ACTIVE NOT RECRUITING
NCT05983068
PHASE4

A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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)

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-02-22

Completion Date

2026-08-07

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DRUG

dupilumab

solution for injection; by subcutaneous (SC) injection

Locations (4)

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