Liberty Trekids EFC14771
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and long-term safety of dupilumab in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze
IRAS ID
1008405
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-504331-41
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to look at whether Dupilumab, a medicinal product works in children between 2 and <6 years old with uncontrolled asthma and/or severe asthmatic wheeze. Uncontrolled asthma and/or recurrent severe asthmatic wheeze is defined as the recurrence of wheezing episodes despite the use of background controller medications. The study drug, 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). By stopping the activity of IL-4 and IL-13, it is hoped that the study drug may control the body’s immune reaction and reduce inflammation in the lungs caused by asthma. Enrolled participants will receive treatment with dupilumab or placebo which will be randomly assigned. The study will be conducted in 2 parts: part A and an optional part B. Dupilumab or placebo will be administered via subcutaneous (skin) injection during a 52-week treatment period. A child will still continue to use his or her background controller inhaler and reliever as instructed by the study doctor. If a child completes the 52-week treatment period, he/she may enter an optional extension period (Part B of the study) to receive only the study drug. Part B of the study will be focused on collecting safety data and will extend treatment for additional 52 weeks.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0707
Date of REC Opinion
15 Mar 2024
REC opinion
Further Information Favourable Opinion