Table 1.

Key inclusion and exclusion criteria

Key inclusion criteria

• Male or female, aged 18–75 years, weight ≥ 40 kg at visit 1

• Documented physician-diagnosed asthma for ≥12months before visit 1

• Physician-prescribed asthma controller medication with medium- or high-dose ICS for at least 12 months before visit 1 (as per GINA 2018 guidelines) [21]

• Documented use of at least one additional maintenance asthma controller medication (e.g. LABA, LTRA, theophylline or LAMA) for at least 3 months before visit 1

• Predicted normal value for morning prebronchodilator FEV1 > 50% and > 1 L at visit 1 or visit 2

• Documented historical FEV1 reversibility of ≥12% and ≥ 200 mL in the 12 months before visit 1 or at visit 2

• ACQ-6 score ≥ 1.5 at visit 1 or visit 2

Key exclusion criteria

• Any clinically important pulmonary disease, other than asthma, associated with high peripheral eosinophil counts

• Any disorder that could, in the opinion of the investigator, affect the safety of the patient or influence the study findings

• Exacerbation resulting in hospitalization or requiring OCS within 6 weeks of enrolment; more than three asthma exacerbations requiring OCS or hospitalization in the 12 months before visit 1; or exacerbation requiring intubation or admission to the ICU in the year before enrolment

• Any clinically significant infection requiring antibiotic or antiviral treatment within 2 weeks of visit 1 or during the run-in period

• Helminth or parasitic infection diagnosed within 6 months of visit 1 that has not been treated with, or is unresponsive to, standard-of-care therapy

• History of cancer, HIV or hepatitis B or C

• Current smokers or patients with a smoking history of ≥ 10 pack-years

• Use of any marked or investigational biologic agent within 4 months or 5 half-lives of visit 1, or any investigational non-biologic agent within 30 days or 5 half-lives of visit 1

• Use of any immunosuppressive medication within 12 weeks of randomization

• History of anaphylaxis after biologic therapy

• Pregnant, breastfeeding or lactating

ACQ Asthma Control Questionnaire, FEV₁ Forced expiratory volume in 1 s, GINA Global Initiative for Asthma, HIV Human immunodeficiency virus, ICS Inhaled corticosteroid, ICU Intensive care unit, LABA Long-acting β₂ agonist, LAMA Long-acting muscarinic antagonist, LTRA Leukotriene receptor antagonist, OCS Oral corticosteroid