Tezepelumab Home Use Study - PATH-HOME

Study identifier:D5180C00011

ClinicalTrials.gov identifier:NCT03968978

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

216

Study type

Interventional

Age

12 Years - 80 Years

Date

Study Start Date: 21 May 2019

Primary Completion Date: 05 Jun 2020

Study Completion Date: 05 Jun 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2021 by AstraZeneca

Collaborators

Amgen

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: Tezepelumab (AI) Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.	Biological/Vaccine: Tezepelumab (AI) Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Experimental: Tezepelumab (APFS) Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).	Biological/Vaccine: Tezepelumab (APFS) Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).

Documents available

Statistical Analysis Plan (SAP)
Download
Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Sady A Alpizar

Clinical Research Trials of Florida, Inc.