A post-authorisation safety study (PASS) to describe real-world safety and effectiveness of NUCALA (mepolizumab) in paediatric eosinophilic granulomatosis with polyangiitis (EGPA) patients in Europe (218065)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49461
• EU PAS number:
  EUPAS49460
• Study ID:
  49461
• Official title and acronym:
  A post-authorisation safety study (PASS) to describe real-world safety and effectiveness of NUCALA (mepolizumab) in paediatric eosinophilic granulomatosis with polyangiitis (EGPA) patients in Europe (218065)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This multinational, multi-site, case-series will aim to collect data on real-world safety and effectiveness of up to 24 months after the initiation of mepolizumab treatment in paediatric EGPA patients in Europe. In addition, demographic and relevant medical history data will be collected up to 12 months prior to the first dose of mepolizumab.
• Study status:
  Planned

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 18/10/2021

Study start date

Planned: 31/05/2024

Date of final study report

Planned: 24/04/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Study protocol

Initial protocol

Protocol_NUCALA_EGPA_PASS_Protocol_Anonymized.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)