Study identifier:D3250C00059
ClinicalTrials.gov identifier:NCT03953300
EudraCT identifier:2018-003391-13
CTIS identifier:2023-506614-40-00
A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
asthma
Phase 4
No
-
All
81
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Benralizumab Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks | Biological/Vaccine: Benralizumab Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40. |
Placebo Comparator: Placebo Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks | Biological/Vaccine: Placebo Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40. |