Tezepelumab Home Use Study - PATH-HOME

Exclusion Criteria

• • Clinically important pulmonary or systemic diseases other than asthma.
• • History of cancer except basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma of the cervix within 12 months prior to Visit 1.
• • Acute upper or lower respiratory infection requiring antibiotics or antiviral medications finalized <2 weeks before Visit 1 or during screening/run-in period.
• • A helminth parasitic infection diagnosed within 6 months that is untreated or is unresponsive to the standard of care.
• • Smoking history of ≥10 pack years, (includes vaping and e-cigarettes)
• • History of chronic alcohol or drug abuse.
• • Tuberculosis requiring treatment within 12 months prior to V1.
• • History of HIV, Hepatitis B or Hepatitis C.
• • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives.
• • Bronchial thermoplasty in 24 months prior to V1.
• • Anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) to any biologic therapy.
• • Evidence of active liver disease (e.g. jaundice, AST, ALT or ALP >2 times upper limit of normal), ongoing liver disease or inexplicably elevated liver chemistry values.
• • Pregnant, breastfeeding or lactating women.
• • Non-leukocyte depleted whole blood transfusion in 120 days prior to visit 1.