PELISTAD-EX2
Research type
Research Study
Full title
A two-year, Phase 4, open-label, single-arm treatment study to evaluate the long-term effect of dupilumab on skin barrier function in pediatric participants (≥6 to <14 years of age) with moderate-to-severe atopic dermatitis
IRAS ID
1007097
Contact name
Regis Le-Lain
Contact email
Sponsor organisation
Sanofi Aventis Recherche & Developpement
Research summary
Atopic dermatitis (AD) is a skin disorder characterised by very dry skin, causing itching, scratching and skin pain. It is thought to be partially due to increased evaporation of water from the skin and due to the change in the composition of lipids (naturally-occurring molecules which includes fats) in the skin. Treatment of AD can depend on the extent and severity/activity of the disease, and when topical therapies (creams, ointments) are insufficient to treat signs and symptoms, systemic therapy (oral or injected medications) are added. Dupilumab is a medicinal product which works like an antibody. An antibody is a substance produced by the body that helps protect itself against foreign matters (eg, microbes) or against substances produced by the body in case of disease (eg, cancer). In diseases, some mechanisms do not work correctly in the body. Antibodies can be given to block some of these biological mechanisms. In this way, a disease may be treated. Dupilumab blocks substances involved in the immune system (the set of tissues which work together to resist infections or some diseases) called interleukins (IL-4 & IL-13) that are produced in too large quantities in the case of AD. The purpose of this study is to evaluate the long-term effect of dupilumab in pediatric participants (aged ≥6 and <14 years at study entry) on the so-called skin barrier function by analysing the evaporation of water from the skin by using a device which measures Transepidermal Water Loss (TEWL) and skin composition before and after removal of the superficial skin by tape stripping. All enrolled participants will receive treatment with dupilumab via subcutaneous (skin) injection. All sites will have previously conducted the pre-cursor study from which some patients are joining this study. The study will last 2 years (around 112 weeks) and is single arm meaning only one treatment is given.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0060
Date of REC Opinion
18 Sep 2023
REC opinion
Further Information Favourable Opinion