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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.
Age
12 - 75 years
Sex
ALL
Healthy Volunteers
No
Research Site
Andalusia, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Scottsboro, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Alhambra, California, United States
Research Site
Bakersfield, California, United States
Research Site
Newport Beach, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Roseville, California, United States
Start Date
November 19, 2014
Primary Completion Date
October 18, 2017
Completion Date
July 2, 2018
Last Updated
August 21, 2019
2,133
ACTUAL participants
Benralizumab
BIOLOGICAL
Benralizumab
BIOLOGICAL
Lead Sponsor
AstraZeneca
NCT07219173
NCT02327897
NCT07486401
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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