Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

Sponsor
Sanofi
Study ID
NCT05624112
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Dupilumab — DRUG
    Dupilumab solution in a pre-filled syringe for Subcutaneous injection

Study Details

This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping. During the first 2 treatment weeks, patients will have 2 on-site visits/week, followed by one on-site visit/week up to Week 4, one on-site visit every two weeks from Week 4 to Week 8, and one on-site visit every 4 weeks up to Week 16 End of Treatment phase visit (EoT) thereafter. A follow-up visit by phone 4 weeks after the last study assessment at Week 16 will end the study for each participant (End of Study: EoS). The maximum duration of the study per participant will be 24 weeks.

Key Dates

Start date
Nov 25, 2022
Status verified
Sep 2025
Primary completion
Jan 25, 2024
Completion
Jan 25, 2024

Study Design

Enrollment
44 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AD patients
    AD patients aged ≥12 and ≤ 65
  • No Intervention: Healthy volunteers
    Non-treatment healthy volunteers

Primary Outcome Measure

Percent change from baseline in TEWL after 5 skin tape stripping (STS) assessed on lesional skin at Week16 in AD patients. [ Time Frame: From baseline to week16 ]

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