Long-term Access Programme for Subjects who Participated in MEA115921

• Research type

  Research Study

• Full title

  Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)

• IRAS ID

  173584

• Contact name

  Shams-un-nisa Naveed

• Contact email

  sn271@leicester.ac.uk

• Sponsor organisation

  GlaxoSmithKline Research Ltd

• Eudract number

  2014-003162-25

• Research summary

  Research Summary
  Eosinophilic Granulomatosis with Polyangiitis (EGPA), also called Churg-Strauss Syndrome is a rare condition characterised by inflammation of small blood vessels (vasculitis). EGPA can lead to multiple organ damage and is often associated with conditions such as asthma and sinusitis. One important feature of EGPA is an increase in the numbers of white blood cells called eosinophils which are thought to be associated with the disease.

  This study sponsored by GlaxoSmithKline, will provide continued treatment with mepolizumab to only those eligible participants who have completed the previous study (MEA115921).

  Mepolizumab is a monoclonal antibody, not yet approved for doctors to prescribe. Antibodies are molecules found in blood and tissue fluids that help fight infection. Mepolizumab attaches to a naturally occurring body protein called Interleukin 5 (IL-5) and stops it from working. IL-5 controls the life cycle of eosinophils which could have an effect on EGPA.

  Participants will receive mepolizumab as three separate injections (3 x 100mg), given one after the other, every 4 weeks under the skin of the upper arm, thigh or stomach.

  The participant’s treating physician will carefully monitor the participant as per normal standard of care. Participants may continue to receive mepolizumab under in this study until mepolizumab is licensed for treatment of EGPA or until the sponsor discontinues development in EGPA.

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fgsk.trialsummaries.com%252FStudy%252FStudyDetails%253Fid%253D6268%2526tenant%253DMT_GSK_9011%2FNBTI%2FFzy4AQ%2FAQ%2Fadd0b4e7-f5bb-4ed0-ae48-51d7308a0e4f%2F1%2FPIbzqXeB4K&data=05%7C02%7Cleicestersouth.rec%40hra.nhs.uk%7C99d3bb67d5e44019870d08dcdc9ec3f5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627821648048253%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=KVuKXZhwi2ydd8Bykbk6oJ0Szo01E9vbdJNBhXt7rKY%3D&reserved=0
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.gsk-studyregister.com%252Fen%252Ftrial-details%252F%253Fid%253D116841%2FNBTI%2FFzy4AQ%2FAQ%2Fadd0b4e7-f5bb-4ed0-ae48-51d7308a0e4f%2F2%2FfG6Xr4_qXB&data=05%7C02%7Cleicestersouth.rec%40hra.nhs.uk%7C99d3bb67d5e44019870d08dcdc9ec3f5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627821648077856%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=YsflXlDNGvoeIPa%2Fodrod17q6VW2WASpvVgDIDUnx5U%3D&reserved=0

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  15/EM/0077

• Date of REC Opinion

  26 Feb 2015

• REC opinion

  Favourable Opinion