Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
NCT04048343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2022-06-01
Summary
This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.
Conditions
Interventions
- DRUG
-
Biological: Experimental: Tezepelumab
Tezepelumab subcutaneous injection every 4 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Masaharu Shinkai, MD · Tokyo Shinagawa Hospital Medical Corporation Association, Japan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-10
- Primary Completion
- 2021-03-18
- Completion
- 2021-03-18
- FDA Drug
- Yes
Countries
- Japan
Study Locations
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