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Tezepelumab Home Use Study (PATH-HOME)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tezepelumab (APFS)
Tezepelumab (AI)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Severe Uncontrolled Asthma

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tezepelumab (AI)

Tezepelumab (APFS)

Arm Description

Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.

Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Serum Trough Concentrations
PK serum samples were collected pre-dose on dosing visits
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

Full Information

First Posted
April 30, 2019
Last Updated
July 9, 2021
Sponsor
AstraZeneca
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03968978
Brief Title
Tezepelumab Home Use Study
Acronym
PATH-HOME
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Severe Uncontrolled Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 1:1 to either an accessorized pre-filled syringe or an autoinjector. Both will be administered 210 mg tezepelumab subcutaneously.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tezepelumab (AI)
Arm Type
Experimental
Arm Description
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Arm Title
Tezepelumab (APFS)
Arm Type
Experimental
Arm Description
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Intervention Type
Biological
Intervention Name(s)
Tezepelumab (APFS)
Intervention Description
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Intervention Type
Biological
Intervention Name(s)
Tezepelumab (AI)
Intervention Description
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Primary Outcome Measure Information:
Title
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type
Description
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
Secondary Outcome Measure Information:
Title
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction
Description
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
Title
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints)
Description
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
Title
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
Description
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
Title
Serum Trough Concentrations
Description
PK serum samples were collected pre-dose on dosing visits
Time Frame
Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
Title
Anti-drug Antibodies (ADA)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sady A Alpizar, MD
Organizational Affiliation
Clinical Research Trials of Florida, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Research Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Research Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Research Site
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Research Site
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Research Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78221
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
Research Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1L5
Country
Canada
Facility Name
Research Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1394
Country
Japan
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-685
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Research Site
City
Strzelce Opolskie
ZIP/Postal Code
47-100
Country
Poland
Facility Name
Research Site
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Research Site
City
Wieluń
ZIP/Postal Code
98-300
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
53-301
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33907423
Citation
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00011&amp;attachmentIdentifier=34dcbdad-0c68-4350-8ed5-7194d8bb9c97&amp;fileName=D5180C00011-sap-ed-2_(03-Sep-2020)-redacted.pdf&amp;versionIdentifier=
Description
Statistical Analysis Plan (SAP)
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5180C00011&amp;attachmentIdentifier=35e421e0-5181-469c-a1b9-577eb9e0d37b&amp;fileName=D5180C00011-csp-v2_-_CI_Redacted.pdf&amp;versionIdentifier=
Description
Protocol

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Tezepelumab Home Use Study

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