A Long-term Access Programme (LAP) for Subjects with Severe Asthma

• Research type

  Research Study

• Full title

  A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study

• IRAS ID

  186149

• Contact name

  Sabine Derey

• Contact email

  sabine.x.derey@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2015-001152-29

• Research summary

  Summary of Research
  This Long Term Access Programme (LAP) sponsored by GlaxoSmithKline (GSK), will provide continued treatment with mepolizumab to those eligible participants who have completed the previous GSK sponsored studies 200862 and 200363.

  Mepolizumab is a monoclonal antibody, not yet approved for doctors to prescribe. Antibodies are molecules found in blood and tissue fluids. Mepolizumab is an antibody that 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 (a type of white blood cell) which have an effect on severe asthma.

  Participants, including adults, adolescents and children may remain on their normal asthma medication and will be asked to attend clinic visits every 4 weeks. Based on regular standard-of-care management, at each visit the physician will make an overall assessment for the continuation of treatment with mepolizumab. In the event a participant discontinues treatment, for any reason, a follow up assessment will be required 4 weeks after the last dose of mepolizumab. As this is an open label LAP both the doctor and participant will know that the participant is receiving mepolizumab.

  Participants will receive an injection containing mepolizumab under the skin (subcutaneously) of the upper arm or thigh every 4 weeks. Eligible participants will continue to receive mepolizumab under this LAP in the UK until May 2016 or until the Sponsor discontinues development in asthma or until the subject meets any of the withdrawal/stopping criteria. At the end of the LAP participants should be prescribed appropriate asthma therapy as determined by their physician.

  Summary of Results
  Not yet available but will be sent to PIs when avaialable

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  15/EM/0342

• Date of REC Opinion

  13 Oct 2015

• REC opinion

  Further Information Favourable Opinion