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Heart safety of asthma drug tezepelumab under scrutiny in massive study

NCT ID NCT06951867

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tracks over 16,000 teens and adults with severe asthma to see if the drug tezepelumab raises the risk of serious heart problems like heart attack, stroke, or heart-related death. Researchers will compare those taking tezepelumab to those on standard asthma treatments. The goal is to better understand the drug's heart safety in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tezepelumab (brand name TEZSPIRE)
What this could lead to
If it shows tezepelumab is safe for the heart, it could reassure patients and doctors that this asthma treatment does not increase cardiovascular risk.
What could go wrong
This is an observational study, not a controlled trial, so it can only suggest links, not prove cause and effect. Results may be influenced by other factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 16,640 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will be conducted using data sources from Denmark, France, Germany, and the United States of America (USA). The source population will consist of patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period. From this source population, the exposed study population (i.e. patients who initiate tezepelumab treatment) and the unexposed study population (i.e. comparable patients who are unexposed to tezepelumab) will be identified.

Ages

12 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma coronary artery disorder heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular events MACE

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Danish registries (access/analysis)

    RECRUITING

    Copenhagen, Denmark

  • French National Health Data System (SNDS)

    RECRUITING

    Paris, France

  • Healthcare Integrated Research Database (HIRD)

    RECRUITING

    Wilmington, Delaware, 19801, United States

  • Team Gesundheit GKV Claims data (SHI)

    RECRUITING

    Berlin, Germany

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