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Table 1 Key inclusion and exclusion criteria

From: DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma

Key inclusion criteria at randomization

• Female or male patients who have not met tezepelumab discontinuation criteria and have attended the end of treatment visit in either the NAVIGATOR study (NCT03347279) or the SOURCE study (NCT03406078)

Key inclusion criteria for the extended follow-up period

• Patients who were enrolled from the NAVIGATOR study (NCT03347279) who:

 – completed dosing of tezepelumab or placebo up to week 100

 – did not discontinue treatment with either tezepelumab or placebo

 – attended the end of treatment visit (week 104)

Key exclusion criteria at randomization

• Pregnant, breastfeeding or lactating

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

• Any disorder that could, in the opinion of the investigator, affect the safety of the patient throughout the study, influence the study findings or their interpretation, or impede the patient's ability to complete the study

• Current malignancy or malignancy that developed during a predecessor studya

• Treatment with systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine) in the 12 weeks before randomization, with the exception of oral corticosteroids used in the treatment of asthma/asthma exacerbations

• Concurrent enrolment in another clinical study involving an investigational product

• Any clinically meaningful abnormal finding during the predecessor study (demonstrated by physical examination, vital signs, ECG, haematology, clinical chemistry or urinalysis) that could, in the opinion of the investigator, affect the safety of the patient throughout the study, influence the study findings or their interpretation, or impede the patient's ability to complete the study

• Patients with important protocol deviations in either of the predecessor studies, assessed at the discretion of the sponsor

Key exclusion criteria for the extended follow-up period

• Discontinuation of tezepelumab during the treatment period of DESTINATION

• Patients who were enrolled from the SOURCE study (NCT03406078)

  1. ECG electrocardiogram
  2. aPatients with a basal cell carcinoma or a localized squamous cell carcinoma of the skin that was resected for cure will not be excluded