Recruiting

Tezepelumab

Sponsor:

AstraZeneca

Code:

NCT06951867

Conditions

Cardiovascular Events

MACE

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

Tezepelumab

Study Details

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 standard of care treatment for severe asthma.

Conditions

Cardiovascular Events

MACE

Study ID

NCT06951867

Start date

Sep 15, 2025

Status verified date

Aug, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16640 participants

Anticipated

Interventions and Outcome Measures

Arms

tezepelumab severe asthma patients

patients with a diagnosis of severe asthma receiving tezepelumab

tezepelumab unexposed asthma patients

patients with a diagnosis of severe asthma receiving non-tezepelumab standard of care for severe asthma

Interventions

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.

Primary outcome measure

  • composite outcome MACE [ Time Frame: five years from tezepelumab market launch ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Healthcare Integrated Research Database (HIRD)

Recruiting

Wilmington, Delaware, United States, 19801

More Information

Sponsor

AstraZeneca

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • post Marketing Requirements (PMR) study
  • cardiovascular events
  • non-fatal myocardial infarction
  • non-fatal stroke
  • cardiovascular death
  • arrythmias
  • coronary artery disease
  • heart failure
  • myocardial disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-20.