Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tezepelumab Home Use Study (PATH-HOME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03968978
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE May 21, 2019
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03968978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • 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.
  • 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).
  • 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.
  • Serum trough concentrations [ Time Frame: Baseline (Week 0) to Week 24 ]
    Serum trough concentrations at each scheduled visit.
  • Anti-drug antibodies (ADA) [ Time Frame: Baseline (Week 0) to Week 24 ]
    Incidence of anti-drug antibodies.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tezepelumab Home Use Study
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Asthma
Intervention  ICMJE
  • Biological: Tezepelumab (APFS)
    Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
  • Biological: Tezepelumab (AI)
    Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Study Arms  ICMJE
  • Experimental: Tezepelumab (AI)
    Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
    Intervention: Biological: Tezepelumab (AI)
  • Experimental: Tezepelumab (APFS)
    Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
    Intervention: Biological: Tezepelumab (APFS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 23, 2020
Estimated Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Canada,   Japan,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968978
Other Study ID Numbers  ICMJE D5180C00011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Amgen
Investigators  ICMJE
Principal Investigator: Sady A Alpizar, MD Clinical Research Trials of Florida, Inc.
PRS Account AstraZeneca
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP