Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Inclusion Criteria:

• Written informed consent

• Participant must be 12 to 75 years of age

• Documented history of physician-diagnosed asthma requiring treatment with at leastmedium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total dailydose) and a LABA, for at least 12 months prior to Visit (V) 1.

• Documented treatment with medium-dose ICS and LABA for at least 3 months prior toVisit 1 with or without additional asthma controllers (excluding oralcorticosteroids).

• Weight of ≥ 35 kg.

• Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90%predicted

• Documented at least 2 asthma exacerbations in the 12 months prior to the date ofinformed consent.

• ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 toV3) and at V3.

• Evidence of asthma as documented by excessive variability in lung function, asdefined in the protocol.

• Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.

• At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.

Exclusion Criteria:

• Important pulmonary disease other than asthma at the discretion of the investigator,or ever been diagnosed with pulmonary or systemic disease, other than asthma, whichare associated with elevated peripheral eosinophil counts.

• Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acuteupper/lower respiratory infection that requires antibiotics or antiviral medicationwithin 30 days prior to the date informed consent is obtained or during thescreening/run-in period

• Any unstable disorder that in the opinion of the investigator could affect the studyaccording to the study protocol.

• Clinically significant chronic or ongoing active infections requiring systemictreatment (at investigator's discretion)

• Concurrent participation in another clinical study with an IP or apost-authorisation safety study.

• History of alcohol or drug abuse within 12 months prior to the date informed consentis obtained.

• Current smokers or former smokers with a smoking history ≥ 10 pack-years. Formersmokers must have stopped for at least 6 months prior to Visit 1 to be eligible.