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Tezepelumab Home Use Study (PATH-HOME)

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ClinicalTrials.gov Identifier: NCT03968978
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Asthma Biological: Tezepelumab (APFS) Biological: Tezepelumab (AI) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Tezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Biological: Tezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.

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




Primary Outcome Measures :
  1. Proportion of HCPs who successfully administered tezepelumab with the device in clinic [ Time Frame: Week 0 ]
    Proportions will be calculated for each device separately. Successful administration is defined as an injection completed, based on a user-recorded (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned devices.

  2. Proportion of HCPs or subjects/caregivers who successfully administered tezepelumab with the device in clinic [ Time Frame: Week 4 ]
    Proportions will be calculated for each device separately. Successful administration is defined as an injection completed, based on a user-recorded (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned devices.

  3. Proportion of subjects/caregivers who successfully administered tezepelumab with the device in clinic [ Time Frame: Week 8 ]
    Proportions will be calculated for each device separately. Successful administration is defined as an injection completed, based on a user-recorded (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned devices.

  4. Proportion of subjects/caregivers who successfully administered tezepelumab with the device at home [ Time Frame: Week 12 ]
    Proportions will be calculated for each device separately. Successful administration is defined as an injection completed, based on a user-recorded (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned devices.

  5. Proportion of subjects/caregivers who successfully administered tezepelumab with the device at home [ Time Frame: Week 16 ]
    Proportions will be calculated for each device separately. Successful administration is defined as an injection completed, based on a user-recorded (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned devices.

  6. Proportion of subjects/caregivers who successfully administered tezepelumab with the device in clinic [ Time Frame: Week 20 ]
    Proportions will be calculated for each device separately. Successful administration is defined as an injection completed, based on a user-recorded (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned devices.


Secondary Outcome Measures :
  1. Proportion of used/returned devices that passed functional tests and visual inspection and showed no evidence of malfunction [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 ]
    Devices that passed functional tests and visual inspection and showed no evidence of malfunction will be evaluated as functional.

  2. Proportion of APFS devices that have been reported as malfunctioning (Product Complaints) [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 ]
    Performance is measured by the proportion of APFS or AI devices that have been reported as malfunctioning (i.e. via Product Complaints).

  3. Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score. [ Time Frame: Baseline (Week 0) to Week 24 ]
    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.

  4. Serum trough concentrations [ Time Frame: Baseline (Week 0) to Week 24 ]
    Serum trough concentrations at each scheduled visit.

  5. Anti-drug antibodies (ADA) [ Time Frame: Baseline (Week 0) to Week 24 ]
    Incidence of anti-drug antibodies.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 either: Airway reversibility after use of an inhaled SABA (FEV1 ≥12% and 200 ml) up to Visit 2 OR documented in the previous 12 months.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968978


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
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United States, Alabama
Research Site Not yet recruiting
Hoover, Alabama, United States, 35244
United States, Arizona
Research Site Not yet recruiting
Gilbert, Arizona, United States, 85234
United States, California
Research Site Not yet recruiting
Northridge, California, United States, 91324
Research Site Recruiting
Palm Desert, California, United States, 92260
Research Site Recruiting
Westminster, California, United States, 92683
United States, Colorado
Research Site Not yet recruiting
Colorado Springs, Colorado, United States, 80907
United States, Florida
Research Site Recruiting
Tampa, Florida, United States, 33607
United States, Georgia
Research Site Not yet recruiting
Savannah, Georgia, United States, 31406
United States, Nebraska
Research Site Not yet recruiting
Omaha, Nebraska, United States, 68114
United States, New Jersey
Research Site Not yet recruiting
Northfield, New Jersey, United States, 08225
United States, Ohio
Research Site Not yet recruiting
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
Research Site Recruiting
Edmond, Oklahoma, United States, 73034
United States, Oregon
Research Site Not yet recruiting
Medford, Oregon, United States, 97504
United States, Texas
Research Site Not yet recruiting
Dallas, Texas, United States, 75235
Research Site Not yet recruiting
McKinney, Texas, United States, 75069
Research Site Not yet recruiting
San Antonio, Texas, United States, 78221
Research Site Not yet recruiting
San Antonio, Texas, United States, 78229
Research Site Recruiting
San Antonio, Texas, United States, 78229
Research Site Not yet recruiting
Waco, Texas, United States, 76712
Canada, Alberta
Research Site Not yet recruiting
Calgary, Alberta, Canada, T2N 1N4
Canada, Ontario
Research Site Not yet recruiting
Ajax, Ontario, Canada, L1S 2J5
Research Site Not yet recruiting
Burlington, Ontario, Canada, L7N 3V2
Research Site Not yet recruiting
Mississauga, Ontario, Canada, L5A 3V4
Research Site Not yet recruiting
Ottawa, Ontario, Canada, K1G-6C6
Research Site Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Research Site Not yet recruiting
Windsor, Ontario, Canada, N8X 1T3
Research Site Not yet recruiting
Windsor, Ontario, Canada, N8X 2G1
Canada, Quebec
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Montreal, Quebec, Canada, H3G 1L5
Research Site Not yet recruiting
Quebec City, Quebec, Canada, G1V 4W2
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Trois-Rivieres, Quebec, Canada, G8T 7A1
Canada
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Quebec, Canada, G1V 4G5
Japan
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Chuo-ku, Japan, 103-0027
Research Site Not yet recruiting
Fukuoka-shi, Japan, 811-1394
Poland
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Kraków, Poland, 31-011
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Kraków, Poland, 31-209
Research Site Not yet recruiting
Strzelce Opolskie, Poland, 47-100
Research Site Not yet recruiting
Tarnów, Poland, 33-100
Research Site Not yet recruiting
Wrocław, Poland, 53-301
Sponsors and Collaborators
AstraZeneca
Amgen
Investigators
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Principal Investigator: Sady A Alpizar, MD Clinical Research Trials of Florida, Inc.

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03968978     History of Changes
Other Study ID Numbers: D5180C00011
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AstraZeneca:
Asthma, Severe Uncontrolled Asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs