At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium 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 695 participants across 79 sites in 4 countries.
Detailed Summary
This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.
Study Details
Timeline
Interventions
Benralizumab subcutaneously on study week 0 until study week 40 inclusive.
Placebo subcutaneously on study week 0 until study week 40 inclusive.