- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048343
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma (NOZOMI)
A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tezepelumab in Japanese Adults and Adolescents With Inadequately Controlled Severe Asthma (NOZOMI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Chuo-ku, Japan, 103-0022
- Research Site
-
Chuo-ku, Japan, 104-0031
- Research Site
-
Sagamihara-shi, Japan, 228-0815
- Research Site
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Shinagawa-ku, Japan, 140-8522
- Research Site
-
Shinjuku-ku, Japan, 169-0073
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
Documented history of at least 1 asthma exacerbation events within 12 months. ACQ-6 score ≥1.5 at screening or on day of registration.
Exclusion Criteria:
Pulmonary disease other than asthma. History of cancer. History of a clinically significant infection. Current smokers or subjects with smoking history ≥10 pack-yrs. History of chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or breastfeeding. History of anaphylaxis following any biologic therapy. Subject randomized in the current study or previous tezepelumab studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tezepelumab
Tezepelumab: Tezepelumab subcutaneous injection
|
Tezepelumab subcutaneous injection every 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Adverse Events
Time Frame: From first dose of study drug until last study visit at Week 64
|
The number of subjects who experienced an AE during on-treatment period was summarised.
|
From first dose of study drug until last study visit at Week 64
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Masaharu Shinkai, MD, Tokyo Shinagawa Hospital Medical Corporation Association, Japan
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5180C00019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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