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Tezepelumab Home Use Study

NCT03968978 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2021-07-29

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Tezepelumab (APFS)

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

BIOLOGICAL

Tezepelumab (AI)

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

Sponsors & Collaborators

Principal Investigators

  • Sady A Alpizar, MD · Clinical Research Trials of Florida, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2020-06-05
Completion
2020-06-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968978 on ClinicalTrials.gov