The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).
This is an open-label safety extension study designed to evaluate the safety and tolerability of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) in severe asthma patients on inhaled corticosteroid and long-acting β2 agonist (ICS-LABA) therapy with or without chronic oral corticosteroids (OCS) and/or other asthma controllers. All patients will receive active drug on the same dosing regimen they received in BORA (NCT02258542). In order to protect the blind of BORA, patients will remain blinded to treatment regimen allocation until they have completed all end of treatment (EOT) assessments in BORA and signed informed consent for participation in this study, after which treatment allocation will be unblinded to both the investigator and the patient.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
447
Benralizumab administered subcutaneously every 4 weeks
Benralizumab administered subcutaneously every 8 weeks
Change From Baseline in Basophils, Full Analysis Set
Change from baseline in hematologic lab parameter of Basophils.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Leukocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Leukocytes.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Lymphocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Lymphocytes.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Neutrophils, Full Analysis Set
Change from baseline in hematologic lab parameter of Neutrophils.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Monocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Monocytes.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Platelets, Full Analysis Set
Change from baseline in hematologic lab parameter of Platelets.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
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Research Site
Scottsboro, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Bakersfield, California, United States
Research Site
Newport Beach, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Roseville, California, United States
Research Site
Sacramento, California, United States
Research Site
San Jose, California, United States
Research Site
Stockton, California, United States
...and 168 more locations
Change From Baseline in Hematocrit, Full Analysis Set
Change from baseline in hematologic lab parameter of Hematocrit.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Erythrocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Erythrocytes.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Hemoglobin, Full Analysis Set
Change from baseline in hematologic lab parameter of Hemoglobin.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
Change from baseline in chemistry test ALT.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set
Change from baseline in chemistry test AST.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Bilirubin, Full Analysis Set
Change from baseline in chemistry test Bilirubin.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Number of Participants With Asthma Exacerbations During Study Period
Asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
Time frame: From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented.
Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
Time frame: From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented.
Change of Blood Eosinophils Count
Change from Baseline to End of Treatment in blood eosinophils count.
Time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study
Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
Time frame: From week 0 to week 184 in study treatment period and plus 12 weeks follow up period
Duration of Exposure
Duration of exposure
Time frame: From week 0 to week 184 in study treatment period