Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2019-05-21
2020-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Tezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Tezepelumab (APFS)
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Tezepelumab (APFS)
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Interventions
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Tezepelumab (APFS)
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Tezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Eligibility Criteria
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Inclusion Criteria
* Documented physician-diagnosed asthma for at least 12 months.
* Evidence of asthma as documented by post BD (albuterol/salbutamol) reversibility of FEV1 ≥ 12% AND ≥200 mL (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 μg/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.
Exclusion Criteria
* 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.
12 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Sady A Alpizar, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Trials of Florida, Inc.
Locations
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Research Site
Hoover, Alabama, United States
Research Site
Gilbert, Arizona, United States
Research Site
Northridge, California, United States
Research Site
Palm Desert, California, United States
Research Site
Westminster, California, United States
Research Site
Tampa, Florida, United States
Research Site
Savannah, Georgia, United States
Research Site
Omaha, Nebraska, United States
Research Site
Northfield, New Jersey, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Edmond, Oklahoma, United States
Research Site
Medford, Oregon, United States
Research Site
Dallas, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Calgary, Alberta, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Chūōku, , Japan
Research Site
Fukuoka, , Japan
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Poznan, , Poland
Research Site
Poznan, , Poland
Research Site
Strzelce Opolskie, , Poland
Research Site
Tarnów, , Poland
Research Site
Wieluń, , Poland
Research Site
Wroclaw, , Poland
Countries
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References
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Alpizar S, Megally A, Chen C, Raj A, Downie J, Colice G. Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma. J Asthma Allergy. 2021 Apr 19;14:381-392. doi: 10.2147/JAA.S305114. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D5180C00011
Identifier Type: -
Identifier Source: org_study_id
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