Tezepelumab Home Use Study

Asthma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968978
• Other study ID #: D5180C00011
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2019
• Est. completion date: June 5, 2020

Study information

• Verified date: July 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Tezepelumab (APFS)
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
• Tezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.

Locations

Country	Name	City	State
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Trois-Rivieres	Quebec
Canada	Research Site	Windsor	Ontario
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Poland	Research Site	Bialystok
Poland	Research Site	Kraków
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Strzelce Opolskie
Poland	Research Site	Tarnów
Poland	Research Site	Wielun
Poland	Research Site	Wroclaw
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Gilbert	Arizona
United States	Research Site	Hoover	Alabama
United States	Research Site	McKinney	Texas
United States	Research Site	Medford	Oregon
United States	Research Site	Northfield	New Jersey
United States	Research Site	Northridge	California
United States	Research Site	Omaha	Nebraska
United States	Research Site	Palm Desert	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Savannah	Georgia
United States	Research Site	Tampa	Florida
United States	Research Site	Westminster	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Amgen

Countries where clinical trial is conducted

United States,  Canada,  Japan,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Secondary	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.	Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Secondary	Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score	The ACQ-6 captures asthma symptoms and short-acting ß2-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.	Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
Secondary	Serum Trough Concentrations	PK serum samples were collected pre-dose on dosing visits	Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
Secondary	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	Pre-treatment on dosing days until end of follow-up (Week 36) per protocol

External Links

•   Protocol
•   Statistical Analysis Plan (SAP)