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NCT Number: NCT06998095

Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea

The objectives of this study are to describe the incidence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma or CRSwNP in South Korea.

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Chronic Rhinosinusitis With Nasal Polyps(CRSwNP) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective, single-arm, multicenter, observational study to evaluate the safety and effectiveness of tezepelumab from treatment initiation up to 24 weeks in patients who are prescribed tezepelumab according to its approved indication in South Korea.

The effectiveness assessment will estimate the proportion of patients with improved asthma control or a clinically meaningful improvement in SNOT-22 scores, from treatment initiation up to 24 weeks after the initiation of tezepelumab.

This study design will reflect the actual management of these subjects in routine clinical practice. The treating physician will determine the treatment plan, as well as the frequency of laboratory and clinical assessment, if necessary, based on routine practice.

All patients will be evaluated for safety during tezepelumab use (24 weeks) or within 30 days after the last administration of tezepelumab if the patients discontinued tezepelumab before 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information
  • Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion criteria

  • Other off-label indications according to the locally approved prescribing information
  • Current participation in any interventional trial

Treatment and study plan

Primary outcomes

  1. Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

  2. Characterization of AEs/ADRs (nature, maximum severity, causality to tezepelumab, actions taken, and outcomes)

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

    To describe the nature (type), severity, and causality of adverse events (AEs)/adverse drug reactions (ADRs) and actions taken to address AEs among patients receiving tezepelumab for approved indications in routine clinical practice.

Secondary outcomes

  1. Proportion of patients with severe asthma who show improvement in asthma control

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

    A patient whose GINA assessment changed from "Uncontrolled" at baseline to "Partly controlled" or "Well Controlled" at end of study or from "Partly controlled" at baseline to "Well Controlled" at end of study is defined as "Improved".

  2. Proportion of CRSwNP patients achieving clinically meaningful improvement in SNOT-22

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

    Changes from baseline in SNOT-22 total scores, including the minimal clinically important difference(MCID) of 8.9 points, will be assessed to determine clinically meaningful improvement.

  3. Incidence rate of AEs, ADRs, SAEs, SADRs,unexpected AEs/ADRs, unexpected SAEs/SADRs

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

Other outcomes

  1. Incidence proportion of AEs by demographic and clinical characteristics

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

  2. Proportion of patients with improved asthma control by demographic and clinical characteristics

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

    Proportion achieving "improved" GINA control (as defined above) summarized within prespecified subgroups (demographics, baseline clinical characteristics), with exact 95% CIs.

  3. Proportion of patients with clinically meaningful improvement in SNOT-22 scores by demographic and clinical characteristics

    Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.

    Proportion of SNOT-22 responders (≥8.9-point reduction) summarized within prespecified subgroups (demographics, baseline clinical characteristics), with exact 95% CIs.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: Tezepelumab

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 31, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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