At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 447 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 Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
In Brief
A Phase 3 clinical trial evaluating Benralizumab for Asthma. Completed, enrolled 447 participants across 178 sites in 15 countries.
Detailed Summary
The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Bulgaria, Canada, Chile, Czechia, France, Germany, Poland, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJun 2016
Primary CompletionJun 2020
TodayJul 2026
First PostedJun 22, 2016
Enrollment StartJun 30, 2016
Primary CompletionJun 18, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.0 years ago
Interventions
Benralizumabbiological
Benralizumab administered subcutaneously every 4 weeks
Benralizumabbiological
Benralizumab administered subcutaneously every 8 weeks