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
Started

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Record History

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  1. Notable Primary completion date: May 29, 2026 to Apr 29, 2027
    • Study completion date: Aug 7, 2026 to May 19, 2027
    v11
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (4)
    v10
  3. Minor Study sites: 3 to 4v9
  4. Minor Study sites: 2 to 3v8
  5. Minor Study sites: 1 to 2v7
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  1. Minor Start date changed from estimate of Jan 31, 2024 to Feb 22, 2024v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 4 words
    v5
  3. Notable Start date: Oct 31, 2023 to Jan 31, 2024v4
  4. Minor Primary completion date: May 22, 2026 to May 29, 2026
    • Study completion date: Jun 3, 2026 to Aug 7, 2026
    v3
  5. Notable Start date: Aug 25, 2023 to Oct 31, 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
286 trials monitored
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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)
Trial Details
NCT Number NCT05983068
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)
Dermatitis Atopic
Related terms Dermatitis, Atopic
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov