Study identifier:D3250C00018
ClinicalTrials.gov identifier:NCT01914757
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
asthma
Phase 3
No
-
All
2508
Interventional
12 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2016 by AstraZeneca
AstraZeneca
-
The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
Location
Location
Ciudad de Buenos Aires, Argentina
Location
Ranelagh, Argentina
Location
Buenos Aires, Argentina
Location
Mar del Plata, Argentina
Location
Ciudad Autónoma de Bs. As., Argentina
Location
Concepción del Uruguay, Argentina
Location
Godoy Cruz, Argentina
Location
Mendoza, Argentina
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab 30 mg q.4 weeks Benralizumab administered subcutaneously every 4 weeks | Biological/Vaccine: Benralizumab Benralizumab subcutaneously on study week 0 until study week 52 inclusive. Other Name: Benralizumab |
Experimental: Benralizumab 30 mg q.8 weeks Benralizumab administered subcutaneously every 8 weeks | Biological/Vaccine: Benralizumab Benralizumab subcutaneously on study week 0 until study week 52 inclusive. Other Name: Benralizumab |
Placebo Comparator: Placebo Placebo administered subcutaneously | Biological/Vaccine: Placebo Placebo subcutaneously on study week 0 until study week 52 inclusive. Other Name: Placebo |
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