The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) 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
121
Benralizumab administered subcutaneously every 4 weeks
Research Site
Northridge, California, United States
Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home
Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.
Time frame: Week 12, Week 16, Week 12 and 16
Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.
Time frame: Week 12, Week 16
Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.
Time frame: Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score
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.
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Research Site
Riverside, California, United States
Research Site
Westminster, California, United States
Research Site
Miami, 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
Canton, Ohio, United States
Research Site
Edmond, Oklahoma, United States
...and 15 more locations
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