Study identifier:D3250C00021
ClinicalTrials.gov identifier:NCT02258542
EudraCT identifier:N/A
CTIS identifier:N/A
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)
asthma
Phase 3
No
-
All
2133
Interventional
12 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verified 01 Jul 2019 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Quezon City, Philippines, 1101
Location
Lipa City, Philippines, 4217
Location
Iloilo City, Philippines, 5000
Location
Istanbul, Turkey, 34098
Location
Ankara, Turkey, 06230
Location
Bursa, Turkey, 16059
Location
Izmir, Turkey, 35100
Location
Adana, Turkey, 01330
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab Arm A Benralizumab administered subcutaneously | Biological/Vaccine: Benralizumab Benralizumab administered subcutaneously |
Experimental: Benralizumab Arm B Benralizumab administered subcutaneously | Biological/Vaccine: Benralizumab Benralizumab administered subcutaneously |
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