ITULAZAX Post Authorization Safety (IPAS) Study: A prospective, non-interventional study assessing the safety and tolerability of ITULAZAX in adults with tree pollen allergy in real-life practice (IPAS Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49339
• EU PAS number:
  EUPAS31470
• Study ID:
  49339
• Official title and acronym:
  ITULAZAX Post Authorization Safety (IPAS) Study: A prospective, non-interventional study assessing the safety and tolerability of ITULAZAX in adults with tree pollen allergy in real-life practice (IPAS Study)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Germany

  Netherlands

  Norway

  Sweden
• Study description:
  Non-interventional, observational, multi-site, open-label multi-national PASS to investigate the safety and tolerability of ITULAZAX in adult patients in a real-life setting in Germany, the Netherlands, Denmark, Sweden, Norway and Finland.
• Study status:
  Finalised

Research institutions and networks

Institutions

ALK-Abelló

Multiple centres: 178 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 10/09/2019

Actual: 18/02/2020

Study start date

Planned: 30/11/2019

Actual: 22/04/2020

Data analysis start date

Planned: 30/09/2022

Actual: 16/01/2023

Date of final study report

Planned: 30/06/2023

Actual: 09/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ALK-Abelló Arzneimittel GmbH

Study protocol

Initial protocol

190910-NIS-PASS-ITULAZAX Final Protocol version 1.0

Updated protocol

20220811-NIS-PASS-ITULAZAX Final Protocol version 4.0_04102022_update sponsor address

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable