Study identifier:D3250C00020
ClinicalTrials.gov identifier:NCT02075255
EudraCT identifier:N/A
CTIS identifier:N/A
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)
asthma
Phase 3
No
-
All
220
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2018 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab Arm A Benralizumab administered subcutaneously every 4 weeks | Biological/Vaccine: Benralizumab Benralizumab administered subcutaneously every 4 weeks |
Experimental: Benralizumab Arm B 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. | Biological/Vaccine: Benralizumab 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. |
Placebo Comparator: Placebo Placebo administered subcutaneously every 4 weeks | Biological/Vaccine: Placebo Placebo subcutaneously on study week 0 until study week 24 inclusive. |