At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 162 enrolled
Drug / intervention
Benralizumabbiological
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, Functionality, Reliability, and Performance Study of an Accessorized Pre-filled Syringe With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GREGALE)
In Brief
A Phase 3 clinical trial evaluating Benralizumab for Asthma. Completed, enrolled 162 participants across 23 sites in 2 countries.
Detailed Summary
The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartApr 2015
Primary CompletionMar 2016
TodayJul 2026
First PostedApr 16, 2015
Enrollment StartApr 27, 2015
Primary CompletionMar 14, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.2 years ago
Interventions
Benralizumabbiological
Benralizumab administered subcutaneously every 4 weeks