The purpose of the study is to assess functionality, performance, and reliability of an accessorized pre-filled syringe (APFS) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Benralizumab administered subcutaneously every 4 weeks
Research Site
Fountain Valley, California, United States
Research Site
Walnut Creek, California, United States
Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home
Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.
Time frame: Week 12, Week 16, and Weeks 12 and 16
Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of "Yes" to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.
Time frame: Week 12, Week 16
Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.
Time frame: Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score
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Research Site
Celebration, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Albany, Georgia, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Bellevue, Nebraska, United States
...and 13 more locations
The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.
Time frame: Week 0 (baseline) and weeks 4, 8, 12, 16, 20
The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab
Mean PK Concentration at each visit
Time frame: Baseline, Week 8, Week 20, and Week 28
The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels
Blood eosinophil counts by timepoint
Time frame: Baseline, Week 20, and Week 28
The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive
Time frame: Baseline until Week 28