At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,133 enrolled
Drug / intervention
Benralizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Benralizumab for Asthma. Completed, enrolled 2,133 participants across 429 sites in 24 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Japan, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartNov 2014
Primary CompletionOct 2017
Study CompletionJul 2018
TodayJul 2026
First PostedOct 7, 2014
Enrollment StartNov 19, 2014
Primary CompletionOct 18, 2017
Study CompletionJul 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.7 years ago
Interventions
Benralizumabbiological
Benralizumab administered subcutaneously
Benralizumabbiological
Benralizumab administered subcutaneously