Study identifier:MI-CP220
ClinicalTrials.gov identifier:NCT01238861
EudraCT identifier:2010-020126-17
CTIS identifier:N/A
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults with Uncontrolled Asthma
asthma
Phase 2
No
-
All
964
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2016 by MedImmune, LLC
MedImmune, LLC
MedImmune Ltd.
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Eosinophilic phenotype (EOS+) Placebo EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo injections subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. | Other: Placebo EOS+ and EOS- participants received two placebo injections subcutaneously. |
Experimental: EOS+ Benralizumab (2 mg) EOS+ participants received single benralizumab 2 milligram (mg) injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. | Biological/Vaccine: Benralizumab 2 mg EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously. Other Name: MEDI-563 |
Experimental: EOS+ Benralizumab (20 mg) EOS+ participants received single benralizumab 20 mg injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. | Biological/Vaccine: Benralizumab 20 mg EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously. Other Name: MEDI-563 |
Experimental: EOS+ Benralizumab (100 mg) EOS+ participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. | Biological/Vaccine: Benralizumab 100 mg EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously. Other Name: MEDI-563 |
Placebo Comparator: Non-eosinophil phenotype (EOS-) Placebo EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. | Other: Placebo EOS+ and EOS- participants received two placebo injections subcutaneously. |
Experimental: EOS- Benralizumab (100 mg) EOS- participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40. | Biological/Vaccine: Benralizumab 100 mg EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously. Other Name: MEDI-563 |