A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma

AstraZeneca KK0 个研究点目标入组 16 人开始时间: 2019年6月19日最近更新: 2023年10月17日

适应症

试验速览

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•Male or female, age 12 to 80 years
•- Documented physician-diagnosed asthma for at least 12 months
•- Evidence of asthma as documented by post BD (albuterol/salbutamol) reversibility of FEV1 12% or more AND 200 mL or more (15-60 min after administration of 4 puffs of albuterol/salbutamol), documented either: in the previous 12 months prior to V1, OR demonstrated at V1, V1A, or at V2.
•- Documented history of current treatment with medium- or high-dose ICS for at least 6 months and at least one additional asthma controller medication according to standard practice of care. ICS dose must be greater than or equal to 500 microgram/day fluticasone propionate dry powder formulation or equivalent daily
•- Morning pre-BD FEV1 of >50% predicted normal at Visit 1, Visit 1A, or Visit 2

•- 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 or more, (includes vaping and e-cigarettes)
•- History of chronic alcohol or drug abuse
•- Tuberculosis requiring treatment within 12 months prior to V1
•- 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.

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