Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China

Sponsor
Sanofi
Study ID
NCT05680298
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Dupilumab — DRUG
    solution for injection, Subcutaneous injection

Study Details

This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in approximately 20 pediatric patients with moderate-to-severe AD (not more than 24 patients aged ≥6 and \<12 years old), and a 12-week follow-up period. Patients will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 End of Treatment (EoT) phase visit, and every 6-weeks thereafter during the follow-up period and by this will end the study for each participant (End of Study \[EoS\]). The maximum duration of the study per participant will be 32 weeks (including screening period). Skin barrier function in approximately 10 healthy volunteers (not more than 20 healthy participants aged ≥6 and \<12 years old) matched for age (match on age ±2 years), gender, location of targeted lesion area, and study site to the AD cases will be assessed in a similar manner at baseline, and will have 1 on-site visit/week, up to Week 4, 1 on-site visit every 2 weeks from Week 4 to Week 8, and 1 on-site visit every 4 weeks from Week 8 to Week 16 EoT phase visit, and every 6-weeks thereafter during the follow-up period, serving as a reference comparator for skin barrier function.

Key Dates

Start date
Feb 22, 2023
Status verified
Feb 2025
Primary completion
Dec 22, 2023
Completion
Mar 15, 2024

Study Design

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

Arms

  • Experimental: AD patients
    Pediatric patients (≥6 and \<12 years of age) with moderate-to-severe AD will receive a SC injection of dupilumab depending on the body weight
  • No Intervention: Healthy volunteers
    Except for IMPs administration, skin barrier function assessments for healthy volunteers are conducted at the same time and in the same measurement conditions as for AD patients.

Primary Outcome Measure

Percent change from baseline in TEWL after 5 STS assessed on lesional skin at Week 16 in AD patients. [ Time Frame: From baseline to week16 ]

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