At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
Benralizumab +2 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, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy (ZONDA)
In Brief
A Phase 3 clinical trial evaluating Benralizumab and Placebo for Asthma. Completed, enrolled 220 participants across 87 sites in 12 countries.
Detailed Summary
The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Bulgaria, Canada, Chile, France, Germany, Poland, South Korea, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionAug 2016
TodayJul 2026
First PostedMar 3, 2014
Enrollment StartApr 28, 2014
Primary CompletionAug 8, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.3 years ago
Interventions
Benralizumabbiological
Benralizumab administered subcutaneously every 4 weeks
Placebobiological
Placebo subcutaneously on study week 0 until study week 24 inclusive.
Benralizumabbiological
Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.