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)

A randomised, double-blind, parallel-group, placebo-controlled, time-to-first-asthma-exacerbation event study designed. There will be a screening period of 2 months to allow adequate time for the eligibility criteria to be evaluated. The screening period may be reduced to not lesser than 4 weeks from Visit 2a. Furthermore, the Screening Period may be extended up to 12 weeks (or longer, if deemed necessary by the investigator), to accommodate treatment. Visit 2 will be split into Part A (Visit 2a) and Part B (Visit 2b) to reassess eligibility prior to randomisation and first dose of study treatment administration. Patients will be randomised 1:1 to receive benralizumab or placebo. The treatment period will consist of 2 parts: double-blind (DB) treatment period and open-label extension (OLE) period. The initial placebo-controlled, DB treatment period will be of variable duration. The minimum duration of treatment in the DB treatment period for each patient will be 16 weeks. Patient will continue in the DB treatment period until the patient experiences an exacerbation or the required number of events have been observed in the study, whichever occurs sooner. All patients who experience an asthma exacerbation in the DB treatment period may enter the OLE period. The OLE period will be 48 weeks in the ≥ 12 to < 18-year-old age group and 2 years (104 weeks) in the ≥6 to < 12-year-old age group, where all patients will receive benralizumab. An end-of-the-treatment visit will occur 8 weeks after the last dose in the OLE.