Table 1.

Key inclusion and exclusion criteria

Key inclusion criteria

• Male or female, 12–80 years old, weight ≥40 kg at visit 1

• Documented physician-diagnosed asthma for ≥12 months before visit 1, and receiving medium- or high-dose ICS (as per GINA 2017 guidelines) for 12 months before visit 1

• Documented treatment with ICS (total daily dose corresponding to fluticasone propionate ≥500 μg dry powder formulation equivalent) plus at least one additional maintenance asthma controller medication (e.g. LABA, LTRA, theophylline) for ≥3 months before visit 1

• Morning pre-bronchodilator FEV1 <80% predicted normal (<90% for patients 12–17 years old) at either visit 2 or visit 2a

• Documented historical FEV1 reversibility of ≥12% and ≥200 mL in the 12 months before visit 1 OR post-bronchodilator (albuterol/salbutamol) FEV1 reversibility ≥12% and ≥200 mL at vist 2 or visit 2a

• ACQ-6 score ≥1.5 at screening and at randomization

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

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

• Helminth or parasitic infection diagnosed in the 6 months before 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 marketed or investigational biologic agent in the 4 months or 5 half-lives before visit 1, or any investigational non-biologic agent in the 30 days or 5 half-lives before visit 1

• Use of any immunosuppressive medication in the 12 weeks before randomization

• History of anaphylaxis after biologic therapy

• Pregnant, breastfeeding or lactating

ACQ-6 Asthma Control Questionnaire-6; FEV₁ Forced expiratory volume in 1 s; GINA Global Initiative for Asthma; HIV Human immunodeficiency virus; ICS Inhaled corticosteroids; LABA Long-acting β₂ agonist; LTRA Leukotriene receptor antagonist