Safety and effectiveness of NUCALA (mepolizumab) in paediatric

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  322213

• Contact name

  Atul Gupta

• Contact email

  Atulgupta1@nhs.net

• Sponsor organisation

  GlaxoSmithKline

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  Paediatric Eosinophilic Granulomatosis with polyangiitis (EGPA) is a rare autoimmune disease and is characterised by small vessel vasculitis in association with asthma, sinusitis, and pulmonary infiltrates. Multiple organs can be affected including the heart, lungs, skin, gastrointestinal tract, kidneys, and nervous system.
  Paediatric EGPA is extremely rare, with approximately 100 cases identified in the
  literature through 2020.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  23/EM/0107

• Date of REC Opinion

  11 Aug 2023

• REC opinion

  Further Information Favourable Opinion