At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,681 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, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma
In Brief
A Phase 3 clinical trial evaluating Benralizumab and Placebo for Asthma. Completed, enrolled 2,681 participants across 275 sites in 17 countries.
Detailed Summary
The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustralia, Brazil, Bulgaria, Czechia, France, Italy, Mexico, Peru, Poland, Russia, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartSep 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedAug 27, 2013
Enrollment StartSep 19, 2013
Primary CompletionApr 5, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.8 years ago
Interventions
Benralizumabbiological
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Placebobiological
Placebo subcutaneously on study week 0 until study week 44 inclusive.