Tezepelumab Home Use Study

Completed · Phase 3

Conditions studied: Asthma

In brief

This is a multicenter, randomized, open-label, parallel-group study designed to assess healthcare provider and subject/caregiver reported functionality and performance of a single-use accessorized pre-filled syringe (APFS) or autoinjector (AI) with a fixed 210 mg dose of tezepelumab administered subcutaneously in the clinic and in an at-home setting.

Key facts

Study ID

NCT03968978

Run by

AstraZeneca

People needed

216

Starts

2019-05-21

Expected to finish

2020-06-05

Last updated by the study team

2021-07-29

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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% 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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