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Active, not recruiting Observational

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

NCT05729711 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2023-04-04
Last updated
2026-09-29

Condition(s) studied

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

Study 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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (33)

FacilityCityRegionStatus
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 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05729711 on ClinicalTrials.gov ↗ ← All trials in Japan