Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab
Intervention description: Benralizumab administered subcutaneously every 4 weeks
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma,; Bronchial Diseases,; Respiratory Tract Diseases,; Lung Diseases,; Obstructive Lung Diseases,; Benralizumab

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria

          -  Written informed consent for study participation must be obtained prior to any study
             related procedures being performed and according to international guidelines and/or
             applicable European Union (EU) guidelines

          -  Male and female patients aged 18 to 75 years of age at the time of Visit 1

          -  Patient or caregiver must be willing and able to self-administer the IP
             (Investigational product). Caregiver must be age of consent or older at the time of
             Visit 1, if applicable

          -  Weight of ≥40 kg

          -  Evidence of asthma as documented by either: Airway reversibility (FEV1 ≥12% and 200
             ml) demonstrated at Visit 1 or 2 OR documented in the previous 12 months OR; Airflow
             variability in FEV1 ≥20% between pulmonary function testing documented in the 12
             months prior to V2 OR; Airflow variability shown by >20% diurnal variability in peak
             flow observed in the patient's asthma action plan

          -  Documented history of current treatment with ICS (Inhaled corticosteroids) and LABA
             (Long-acting β2 agonists). The ICS and LABA can be parts of a combination product or
             given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day
             fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA
             combination preparations, both the mid- and high-strength maintenance doses approved
             in the local country will meet this ICS criterion. Additional asthma controller
             medications (e.g., LTRAs (Leukotriene receptor antagonists), tiotropium, theophylline,
             oral corticosteroids) are allowed

          -  Morning pre-bronchodilator (pre-BD) FEV1 of >50% predicted at Visit 1 or Visit 2

          -  Not well controlled asthma as documented by either: An ACQ6 (Asthma Control
             Questionnaire 6) ≥1.5 OR; A peak flow of 60-80% predicted OR; An exacerbation, one or
             more, that required oral or systemic corticosteroids in the previous year OR; Any one
             of the following assessed by patient recall over the previous 2-4 weeks: Asthma
             symptoms >2 days/week; OR / Nighttime awakenings 1 or more/week; OR / Short acting
             beta2-agonist use for symptom control (not for prevention of exercise induced asthma)
             >2 days/week

        Exclusion criteria:

          -  Clinically important pulmonary disease other than asthma (eg, active lung infection,
             COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis,
             cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha
             1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with
             pulmonary or systemic disease, other than asthma, that are associated with elevated
             peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis,
             Churg-Strauss syndrome, hypereosinophilic syndrome)

          -  Any disorder, including, but not limited to, cardiovascular, gastrointestinal,
             hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
             hematological, psychiatric, or major physical impairment that is not stable in the
             opinion of the Investigator and could: Affect the safety of the patient throughout the
             study; Influence the findings of the studies or their interpretations; Impede the
             patient's ability to complete the entire duration of study

          -  Known history of allergy or reaction to the IP formulation

          -  History of anaphylaxis to any biologic therapy

          -  History of Guillain-Barré syndrome

          -  A helminth parasitic infection diagnosed within 24 weeks prior to the date informed
             consent is obtained that has not been treated with, or has failed to respond to
             standard of care therapy

          -  Acute upper or lower respiratory infections requiring antibiotics or antiviral
             medication within 30 days prior to the date informed consent is obtained or during the
             screening period

          -  Any clinically significant abnormal findings in physical examination, vital signs,
             hematology, clinical chemistry, or urinalysis during screening period, which in the
             opinion of the Investigator, may put the patient at risk because of his/her
             participation in the study, or may influence the results of the study, or the
             patient's ability to complete entire duration of the study