NCT05729711

Active Not Recruiting

TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PM...

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

D5180C00034

Study Type

observational

Actual enrollment (reported)

416

Locations

1 country

Sites

33

Timeline

Study Start

April 4, 2023

Actual (reported)

Primary Completion

November 16, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

November 16, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 416 participants
Study completion date: November 16, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 33 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 7, 2023
Actual (reported)
First Posted
February 15, 2023
Actual (reported)
Study Start
April 4, 2023
Actual (reported)
Primary Completion
November 16, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 16, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: September 29, 2026
Status Verified: September 2026
Last Update Submitted: September 28, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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)

You may qualify if:

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)

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (33)

Research Site

Aichi, Japan

Research Site

Akita, Japan

Research Site

Aomori, Japan

Research Site

Chiba, Japan

Research Site

Fukui, Japan

Research Site

Fukuoka, Japan

Research Site

Gifu, Japan

Research Site

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Toshimitsu Tokimoto
AstraZeneca KK
STUDY DIRECTOR

Enrollment

416 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 15, 2023

Study Start

April 4, 2023

Actual (reported)

You may not qualify if:

None

Contact the study team to confirm eligibility.

Gunma, Japan

Research Site

Hiroshima, Japan

Research Site

Hokkaido, Japan

Research Site

Hyōgo, Japan

Research Site

Ibaraki, Japan

Research Site

Ishikawa, Japan

Research Site

Kagawa, Japan

Research Site

Kanagawa, Japan

Research Site

Kumamoto, Japan

Research Site

Kyoto, Japan

Research Site

Mie, Japan

Research Site

Miyagi, Japan

Research Site

Nara, Japan

Research Site

Numakunai, Japan

Research Site

Okayama, Japan

Research Site

Osaka, Japan

Research Site

Ōita, Japan

Research Site

Saitama, Japan

Research Site

Shimane, Japan

Research Site

Shizuoka, Japan

Research Site

Tochigi, Japan

Research Site

Tokyo, Japan

Research Site

Wakayama, Japan

Research Site

Yamagata, Japan

Research Site

Yamaguchi, Japan

Research Site

Yamanashi, Japan

Primary Completion

November 16, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

November 16, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing: Will share
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.
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.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05729711
Data provider: ClinicalTrials.gov
Source updated: 2026-09-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:51 UTC

Locations

JP(33)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations