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RECRUITING
NCT06951867

Tezspire Cardiac Events PASS

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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 standard of care treatment for severe asthma.

Official title: An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab

Key Details

Gender

All

Age Range

12 Years - 130 Years

Study Type

OBSERVATIONAL

Enrollment

16640

Start Date

2025-09-15

Completion Date

2029-05-31

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Tezepelumab

The exposure of primary interest is tezepelumab for severe asthma. Exposure will be assessed based on prescriptions or administrations depending on the data source. A comparable cohort of unexposed patients treated with high-intensity SOC will be identified based on the presence of a trigger exposure (i.e., augmentation or change of the non-biologic high-intensity treatment that does not represent treatment de-escalation) to mirror tezepelumab start in the exposed cohort. Due to the limited knowledge of the cardiovascular profile of biologics, SOC for comparative analyses will only include non-biologic high-intensity treatment.

Locations (4)

Healthcare Integrated Research Database (HIRD)

Wilmington, Delaware, United States

Danish registries (access/analysis)

Copenhagen, Denmark

French National Health Data System (SNDS)

Paris, France

Team Gesundheit GKV Claims data (SHI)

Berlin, Germany