Study identifier:MI-CP196
ClinicalTrials.gov identifier:NCT01227278
EudraCT identifier:2010-020127-52
CTIS identifier:N/A
A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects with Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia
Pulmonary Disease, Chronic Obstructive
Phase 2
No
-
All
421
Interventional
40 Years - 85 Years
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by MedImmune, LLC
MedImmune, LLC
AstraZeneca
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). | Other: Placebo Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). |
Experimental: Benralizumab 100 mg Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). | Biological/Vaccine: Benralizumab 100 mg Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337). Other Name: MEDI-563 |