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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type
Successful administration is defined as an injection completed, based on a used/returned (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned/evaluated devices.
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction
Devices that passed functional tests and visual inspection and showed no evidence of malfunction will be evaluated as functional. Percentages have been calculated by using the number of used and returned devices at specified visit as denominator. Note: A few participants had missing devices. One participant had two AI devices at Week 4.
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints)
Performance is measured by the proportion of APFS or AI devices that have been reported as malfunctioning (i.e. via Product Complaints). Percentages have been calculated by using the number of used and returned devices at specified visit as denominator. Note: A few participants had missing devices. One participant had two AI devices at Week 4.
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
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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
...and 26 more locations
Serum Trough Concentrations
PK serum samples were collected pre-dose on dosing visits
Time frame: Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
Anti-drug Antibodies (ADA)
Anti-drug antibodies (ADA) responses at baseline and/or post baseline. Treatment-induced ADA positive is defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive is defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following IP administration. Treatment-emergent ADA (TE-ADA) positive is defined as either treatment-induced ADA positive or treatment-boosted ADA positive. ADA incidence is the proportion of TE-ADA positive subjects in a population. Persistently positive is defined as ADA positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive
Time frame: Pre-treatment on dosing days until end of follow-up (Week 36) per protocol