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 (TRESPASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000169
• EU PAS number:
  EUPAS1000000169
• Study ID:
  1000000169
• Official title and acronym:
  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 (TRESPASS)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  United States
• Study description:
  The study is a non-interventional, longitudinal, population-based, cohort design using multiple secondary data sources from Denmark, France, Germany, and the United States of America (USA). The study will describe and compare the risk of adverse cardiovascular outcomes in adolescent and adult patients with severe asthma who initiated tezepelumab and in matched patients unexposed to tezepelumab (treated with standard of care for severe asthma).
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/07/2023

Actual: 13/07/2023

Study start date

Planned: 01/05/2025

Data analysis start date

Planned: 01/09/2025

Date of interim report, if expected

Planned: 30/04/2026

Date of final study report

Planned: 31/05/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ASTRAZENECA PHARMACEUTICALS LP

Study protocol

Initial protocol

TRESPASS - Protocol Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)