Tezepelumab Home Use Study

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 (PATH-HOME)

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.