CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 216 enrolled
Drug / intervention
Tezepelumab (APFS) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03968978
NCT03968978Phase 3Completed
CompareCT.gov

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)

AstraZeneca·interventional·Posted May 30, 2019·Updated Jul 29, 2021

In Brief

A Phase 3 clinical trial evaluating Tezepelumab (APFS) and Tezepelumab (AI) for Asthma. Completed, enrolled 216 participants across 36 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada, Japan, Poland, United States
CollaboratorsAmgen

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 30, 2019
Enrollment StartMay 21, 2019
Primary CompletionJun 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.1 years ago

Interventions

Tezepelumab (APFS)biological

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

Tezepelumab (AI)biological

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