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 |