Tezepelumab Home Use Study
Tezepelumab Home Use Study
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.
The study will consist of a screening/run-in period of up to 2 weeks and a treatment period
 of 24 weeks, followed by a post-treatment follow-up period of 12 weeks. During the treatment
 period, one dose of 210 mg tezepelumab will be administered via a single-use APFS or AI
 subcutaneously (SC) every 4 weeks (Q4W) starting at Visit 2 (Week 0) until Visit 7 (Week 20).
 Subjects will be administered tezepelumab at the site during Visits 2 (Week 0), 3 (Week 4), 4
 (Week 8) and 7 (Week 20). At-home administration of tezepelumab will occur during Visit 5
 (Week 12) and Visit 6 (Week 16). Each device will be assessed separately using descriptive
 presentations.
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.