Asthma Clinical Trial
Official title:
A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to
a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than
40 weeks, in this study, will be given the option to transition to an open-label safety
extension study, Study D3250C00037 (MELTEMI).
Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to
enter Study D3250C00037 will remain in this study through IPD or EOT and FU.
At the time of the first interim analysis in Japanese patients, the study regimen for all
patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and
blinding at the site and patient level will remain unchanged.
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