Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Inclusion Criteria:

1. Written informed consent for study participation must be obtained prior to any study
related procedures being performed (local regulations are to be followed in
determining the assent/consent requirements for children and parent[s]/guardian[s])
and according to international guidelines and/or applicable European Union
guidelines.

2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those
patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be
considered an adolescent for the purposes of this trial.

3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose
ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a
LABA, for at least 12 months prior to Visit 1

4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or
without oral corticosteroids and additional asthma controllers.

- For subjects 18 years of age and older, the ICS dose must be >500 mcg/day
fluticasone propionate dry powder formulation or equivalent daily.

- For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone
propionate dry powder formulation or equivalent daily.

Exclusion criteria:

1. Clinically important pulmonary disease other than asthma (e.g. active lung infection,
COPD, 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 (e.g.
allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome,
hypereosinophilic syndrome)

2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal,
hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
haematological, 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

3. 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/run-in period

4. Any clinically significant abnormal findings in physical examination, vital signs,
haematology, clinical chemistry, or urinalysis during screening/run-in 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