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

Study acronym: PELISTAD-EX2
StatusActive, Not Recruiting
PhasePhase 4
SponsorSanofi
Started2024-02-22
View on ClinicalTrials.gov ↗
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)

Amendment record

Amended 10 times since 2023-08-01; most recent filed 2026-04-07. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-04-07
Amendment Study Status v10
2025-05-14
Amendment RecruitingActive, Not Recruiting Study Status, Contacts/Locations v9
2024-06-21
Amendment Study Status, Contacts/Locations v8
2024-04-10
Amendment Study Status, Contacts/Locations v7
2024-03-14
Amendment Study Status, Contacts/Locations v6
2024-03-01
Amendment Study Identification, Study Status, Eligibility v5
2024-02-01
Amendment Not Yet RecruitingRecruiting Study Identification, Study Status, Oversight, Study Description, Eligibility, Contacts/Locations v4
2024-01-23
Amendment Study Status, Oversight v3
2023-09-18
Amendment Study Status v2
2023-09-15
Amendment Study Status v1
2023-08-01
Original filing
Trial Details
NCT Number NCT05983068
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions Dermatitis Atopic
Enrollment 48 participants
Start Date 2024-02-22
Primary Completion 2027-04-29 (estimated)
Study Completion 2027-05-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-13