At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,656 enrolled
Drug / intervention
Benralizumab Arm A +2 moredrug
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.
Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of Exacerbations
In Brief
A Phase 3 clinical trial evaluating Benralizumab Arm A, Benralizumab Arm B, and 1 other intervention for Moderate to Very Severe Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,656 participants across 407 sites in 17 countries.
Detailed Summary
The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Czechia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Romania, Russia, South Africa, South Korea, Spain, Switzerland, United Kingdom, United States
CollaboratorsMedImmune LLC
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartJun 2014
Primary CompletionApr 2018
TodayJul 2026
First PostedMay 15, 2014
Enrollment StartJun 13, 2014
Primary CompletionApr 10, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.1 years ago
Interventions
Benralizumab Arm Adrug
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm Bdrug
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Placebodrug
Placebo subcutaneously on study week 0 until study week 48 inclusive