Tezepelumab Home Use Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Tezepelumab (APFS); Tezepelumab (AI)
Intervention description: Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).; Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:1 to either an accessorized pre-filled syringe or an autoinjector. Both will be administered 210 mg tezepelumab subcutaneously.
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asthma, Severe Uncontrolled Asthma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        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.