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Status:

RECRUITING

Tezspire Cardiac Events PASS

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

IQVIA Pvt. Ltd

Conditions:

Cardiovascular Events

MACE

Eligibility:

All Genders

12-130 years

Brief Summary

The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standar...

Detailed Description

Tezepelumab (brand name: TEZSPIRE®), a human monoclonal antibody specific for the epithelial cell-derived cytokine thymic stromal lymphopoietin (TSLP), was recently launched as a first-in-class biolog...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.
  • Exclusion Criteria for both exposed and unexposed groups include:
  • \<12 months of data availability prior to index date,
  • age \<12 years at index date,
  • history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date
  • for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic
  • matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \[PS\] matching) will be applied to ensure exposed and unexposed patients' comparability

Exclusion

    Key Trial Info

    Start Date :

    September 15 2025

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    May 31 2029

    Estimated Enrollment :

    95574 Patients enrolled

    Trial Details

    Trial ID

    NCT06951867

    Start Date

    September 15 2025

    End Date

    May 31 2029

    Last Update

    January 8 2026

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Healthcare Integrated Research Database (HIRD)

    Wilmington, Delaware, United States, 19801

    2

    Danish registries (access/analysis)

    Copenhagen, Denmark

    3

    French National Health Data System (SNDS)

    Paris, France

    4

    Team Gesundheit GKV Claims data (SHI)

    Berlin, Germany