tezepelumab home use study

Conditions: 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.

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.

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.

Keywords: asthma, severe uncontrolled asthma