At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,508 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, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
In Brief
A Phase 3 clinical trial evaluating Benralizumab and Placebo for Asthma. Completed, enrolled 2,508 participants across 215 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Chile, Germany, Japan, Philippines, Poland, Romania, Sweden, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionMar 2016
TodayJul 2026
First PostedAug 2, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.9 years ago
Interventions
Benralizumabbiological
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebobiological
Placebo subcutaneously on study week 0 until study week 52 inclusive.