clinical trial · NCT05729711

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

AstraZeneca·—·active not recruiting·n = 416

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

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

started

Apr 4, 2023

primary completion

Nov 16, 2029

completion

Nov 16, 2029

last updated

Mar 27, 2026

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.

official title

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

full record on clinicaltrials.gov ↗

sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol