Study identifier:MI-CP186
ClinicalTrials.gov identifier:NCT00768079
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults
asthma
Phase 2
No
-
All
110
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Oct 2020 by MedImmune, LLC
MedImmune, LLC
-
The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.
The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) (0.3 milligram per kilogram [mg/kg] of body weight and 1.0 mg/kg of body weight) on the proportion of adult subjects with asthma exacerbations (relapse and de novo) who required an urgent healthcare visit for treatment of an acute asthma exacerbation.
Location
Location
New Hyde Park, NY, United States, 11040
Location
Cleveland, OH, United States, 44109
Location
Detroit, MI, United States, 48202
Location
Stony Brook, NY, United States, 11794-8350
Location
East Meadow, NY, United States, 11554
Location
Tampa, FL, United States, 33613
Location
Providence, RI, United States, 2903
Location
Greenville, NC, United States, 27834
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0. | Other: Placebo A single dose of placebo matched to benralizumab (MEDI-563) intravenous infusion over at least 30 minutes on Day 0. |
Experimental: Benralizumab 0.3 mg/kg A single dose of benralizumab (MEDI-563) 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion over at least 30 minutes on Day 0. | Biological/Vaccine: Benralizumab A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0. Other Name: MEDI-563 |
Experimental: Benralizumab 1.0 mg/kg A single dose of benralizumab (MEDI-563) 1.0 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0. | Biological/Vaccine: Benralizumab A single dose of benralizumab (MEDI-563) 0.3 or 1 mg/kg of body weight intravenous infusion over at least 30 minutes on Day 0. Other Name: MEDI-563 |
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