TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)

April 23, 2024 updated by: AstraZeneca

TEZSPIRE Subcutaneous Injection 210mg Specific Use-results Study (Long Term) in Patients With Bronchial Asthma.

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

  1. Development of related AEs
  2. Contributing factors possibly having an impact on the safety and effectiveness
  3. Development of unexpected related AEs

Study Overview

Status

Recruiting

Conditions

Detailed Description

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

  1. Development of related AEs
  2. Contributing factors possibly having an impact on the safety and effectiveness
  3. Development of unexpected related AEs

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Aichi, Japan
        • Active, not recruiting
        • Research Site
      • Aichi, Japan
        • Recruiting
        • Research Site
      • Akita, Japan
        • Active, not recruiting
        • Research Site
      • Aomori, Japan
        • Active, not recruiting
        • Research Site
      • Chiba, Japan
        • Recruiting
        • Research Site
      • Chiba, Japan
        • Active, not recruiting
        • Research Site
      • Fukui, Japan
        • Active, not recruiting
        • Research Site
      • Fukuoka, Japan
        • Active, not recruiting
        • Research Site
      • Fukuoka, Japan
        • Recruiting
        • Research Site
      • Gifu, Japan
        • Recruiting
        • Research Site
      • Gunma, Japan
        • Recruiting
        • Research Site
      • Gunma, Japan
        • Withdrawn
        • Research Site
      • Hiroshima, Japan
        • Recruiting
        • Research Site
      • Hiroshima, Japan
        • Active, not recruiting
        • Research Site
      • Hokkaido, Japan
        • Recruiting
        • Research Site
      • Hokkaido, Japan
        • Active, not recruiting
        • Research Site
      • Hyogo, Japan
        • Recruiting
        • Research Site
      • Ibaraki, Japan
        • Active, not recruiting
        • Research Site
      • Ibaraki, Japan
        • Recruiting
        • Research Site
      • Ishikawa, Japan
        • Recruiting
        • Research Site
      • Iwate, Japan
        • Recruiting
        • Research Site
      • Iwate, Japan
        • Active, not recruiting
        • Research Site
      • Kagawa, Japan
        • Active, not recruiting
        • Research Site
      • Kanagawa, Japan
        • Recruiting
        • Research Site
      • Kanagawa, Japan
        • Active, not recruiting
        • Research Site
      • Kumamoto, Japan
        • Recruiting
        • Research Site
      • Kumamoto, Japan
        • Not yet recruiting
        • Research Site
      • Kyoto, Japan
        • Recruiting
        • Research Site
      • Kyoto, Japan
        • Active, not recruiting
        • Research Site
      • Mie, Japan
        • Recruiting
        • Research Site
      • Mie, Japan
        • Withdrawn
        • Research Site
      • Miyagi, Japan
        • Active, not recruiting
        • Research Site
      • Miyagi, Japan
        • Recruiting
        • Research Site
      • Nara, Japan
        • Recruiting
        • Research Site
      • Nara, Japan
        • Active, not recruiting
        • Research Site
      • Oita, Japan
        • Recruiting
        • Research Site
      • Oita, Japan
        • Active, not recruiting
        • Research Site
      • Okayama, Japan
        • Recruiting
        • Research Site
      • Osaka, Japan
        • Active, not recruiting
        • Research Site
      • Osaka, Japan
        • Recruiting
        • Research Site
      • Saitama, Japan
        • Active, not recruiting
        • Research Site
      • Saitama, Japan
        • Recruiting
        • Research Site
      • Shimane, Japan
        • Recruiting
        • Research Site
      • Shizuoka, Japan
        • Active, not recruiting
        • Research Site
      • Shizuoka, Japan
        • Recruiting
        • Research Site
      • Tochigi, Japan
        • Active, not recruiting
        • Research Site
      • Tochigi, Japan
        • Recruiting
        • Research Site
      • Tochigi, Japan
        • Withdrawn
        • Research Site
      • Tokyo, Japan
        • Recruiting
        • Research Site
      • Tokyo, Japan
        • Active, not recruiting
        • Research Site
      • Tokyo, Japan
        • Withdrawn
        • Research Site
      • Tokyo, Japan
        • Terminated
        • Research Site
      • Toyama, Japan
        • Recruiting
        • Research Site
      • Wakayama, Japan
        • Recruiting
        • Research Site
      • Yamagata, Japan
        • Recruiting
        • Research Site
      • Yamaguchi, Japan
        • Active, not recruiting
        • Research Site
      • Yamanashi, Japan
        • Active, not recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy)

Description

Inclusion Criteria:

  • The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy)

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ADRs
Time Frame: 156 weeks
the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders
156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, Astrazeneca KK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Estimated)

November 16, 2029

Study Completion (Estimated)

November 16, 2029

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5180C00034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA P harma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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.

Clinical Trials on Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)

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