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)
1 other identifier
interventional
65
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2019
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedStudy Start
First participant enrolled
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2021
CompletedResults Posted
Study results publicly available
June 1, 2022
CompletedJune 1, 2022
April 1, 2022
1.8 years
June 5, 2019
March 3, 2022
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Adverse Events
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
Study Arms (1)
Tezepelumab
EXPERIMENTALTezepelumab: Tezepelumab subcutaneous injection
Interventions
Tezepelumab subcutaneous injection every 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (5)
Research Site
Chūōku, 103-0022, Japan
Research Site
Chūōku, 104-0031, Japan
Research Site
Sagamihara-shi, 228-0815, Japan
Research Site
Shinagawa-ku, 140-8522, Japan
Research Site
Shinjuku-ku, 169-0073, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Masaharu Shinkai, MD
Tokyo Shinagawa Hospital Medical Corporation Association, Japan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
August 7, 2019
Study Start
June 10, 2019
Primary Completion
March 18, 2021
Study Completion
March 18, 2021
Last Updated
June 1, 2022
Results First Posted
June 1, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.