PATH-HOME
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)
Sponsor study identifier
interventional
216
4 countries
36
Study Start
May 21, 2019
Actual (reported)Primary Completion
June 5, 2020
Actual (reported)Study Completion
June 5, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 5, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2019
Actual (reported)May 21, 2019
Actual (reported)May 30, 2019
Actual (reported)June 5, 2020
Actual (reported)June 5, 2020
Actual (reported)July 29, 2021
Actual (reported)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.
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
Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints)
Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
Serum Trough Concentrations
Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
Anti-drug Antibodies (ADA)
Pre-treatment on dosing days until end of follow-up (Week 36) per protocol
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
Hoover, Alabama, 35244, United States
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Northridge, California, 91324, United States
Research Site
Palm Desert, California, 92260, United States
Research Site
Westminster, California, 92683, United States
Research Site
Tampa, Florida, 33607, United States
Research Site
Savannah, Georgia, 31406, United States
Alpizar S, Megally A, Chen C, Raj A, Downie J, Colice G. Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma. J Asthma Allergy. 2021 Apr 19;14:381-392. doi: 10.2147/JAA.S305114. eCollection 2021.
Sady A Alpizar, MD
Clinical Research Trials of Florida, Inc.
216 participants (actual enrollment reported by the registry).
First Submitted
April 30, 2019
First Posted
May 30, 2019
Study Start
May 21, 2019
Actual (reported)Contact the study team to confirm eligibility.
Research Site
Omaha, Nebraska, 68114, United States
Research Site
Northfield, New Jersey, 08225, United States
Research Site
Cincinnati, Ohio, 45231, United States
Research Site
Edmond, Oklahoma, 73034, United States
Research Site
Medford, Oregon, 97504, United States
Research Site
Dallas, Texas, 75235, United States
Research Site
McKinney, Texas, 75069, United States
Research Site
San Antonio, Texas, 78221, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Calgary, Alberta, T2N 1N4, Canada
Research Site
Ajax, Ontario, L1S 2J5, Canada
Research Site
Burlington, Ontario, L7N 3V2, Canada
Research Site
Mississauga, Ontario, L5A 3V4, Canada
Research Site
Ottawa, Ontario, K1G 6C6, Canada
Research Site
Windsor, Ontario, N8X 2G1, Canada
Research Site
Montreal, Quebec, H3G 1L5, Canada
Research Site
Québec, Quebec, G1V 4G5, Canada
Research Site
Québec, Quebec, G1V 4W2, Canada
Research Site
Trois-Rivières, Quebec, G8T 7A1, Canada
Research Site
Chūōku, 103-0027, Japan
Research Site
Fukuoka, 811-1394, Japan
Research Site
Bialystok, 15-430, Poland
Research Site
Krakow, 31-011, Poland
Research Site
Poznan, 60-685, Poland
Research Site
Poznan, 60-693, Poland
Research Site
Strzelce Opolskie, 47-100, Poland
Research Site
Tarnów, 33-100, Poland
Research Site
Wieluń, 98-300, Poland
Research Site
Wroclaw, 53-301, Poland
Primary Completion
June 5, 2020
Actual (reported)Study Completion
June 5, 2020
Actual (reported)Last Updated
July 29, 2021
Results First Posted
July 29, 2021
Record last verified: 2021-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
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