*DOMINICA
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)
IRAS ID
1006270
Contact name
Karishma Varsani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-501344-14
Research summary
The Sponsor is performing this study to learn more about the study drug benralizumab, and to find out if it may result in an improvement of severe eosinophilic asthma in patients 6 to less than 18 years old.
Asthma is a lung disease associated with inflammation (swelling) of the air passages. An increase in a type of white bloods cells called eosinophils is related to severe asthma. Benralizumab works by eliminating the eosinophils, which can help control asthma symptoms. This has been demonstrated in adult patients with severe asthma. This study will help examine how effective and safe benralizumab is in; reducing yearly asthma exacerbation, improving lung function, and improving symptoms of severe eosinophilic asthma in adolescents and children.
The study consists of 2 periods, a double-blind (DB) period followed by an open-label extension (OLE) period. Open-label means that participants and the study team will know what study drug participants will receive. Participants will be randomly assigned to receive benralizumab or placebo via an injection with a needle under the skin for the DB period. A placebo is a treatment that will look like benralizumab but without any active medicine in. “Randomly assigned” means that whatever treatment participants get will be by chance, like flipping a coin or drawing names out of a hat. Participants have a 1 in 2 chance (50% chance) of receiving benralizumab or placebo.
The Sponsor of the study is AstraZeneca, AB. This study will include approximately 200 participants aged 6 to 18 years.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0381
Date of REC Opinion
7 Jul 2023
REC opinion
Further Information Favourable Opinion