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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Sanofi
Study ID
NCT05983068
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Dermatitis Atopic

Eligibility Criteria

Sex
ALL
Age
6 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — DRUG
    solution for injection; by subcutaneous (SC) injection

Study Details

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)

Key Dates

Start date
Feb 22, 2024
Status verified
Apr 2026
Primary completion
Apr 29, 2027
Completion
May 19, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pediatric AD participants
    Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.

Primary Outcome Measure

Percent change from baseline in TEWL after 5 STS assessed on lesional skin. [ Time Frame: Baseline to Week 104 ]

Locations (3)

FacilityCityStateZIPSite coordinators
National Jewish Health Medical Center- Site Number : 8400001DenverColorado80206-
SSM Health Saint Louis University Hospital- Site Number : 8400006St LouisMissouri63104-
NYU Langone Medical Center- Site Number : 8400004New YorkNew York10016-

Find similar trials in Denver, CO

By research site
National Jewish Health Medical Center· Denver, COSSM Health Saint Louis University Hospital· St Louis, MONYU Langone Medical Center· New York, NY

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