MedTrace Logo

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

NCT05983068 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-13

No results posted yet for this study

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)

Conditions

  • Dermatitis Atopic

Interventions

DRUG

dupilumab

solution for injection; by subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2027-04-29
Completion
2027-05-19
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983068 on ClinicalTrials.gov