A Safety Study Of Mepolizumab in Patients with Severe Asthma.

• Research type

  Research Study

• Full title

  MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials.

• IRAS ID

  122511

• Contact name

  Ian Pavord

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2012-001644-21

• ISRCTN Number

  NA

• Clinicaltrials.gov Identifier

  NA

• Research summary

  This study, funded by GlaxoSmithKline, will provide long-term safety data on Mepolizumab when administered to participants with severe uncontrolled asthma. Mepolizumab is a monoclonal antibody under development for the treatment of severe uncontrolled asthma. Mepolizumab is not yet approved for doctors to prescribe. Antibodies are molecules in blood and tissue fluids that help fight infection. They recognise and attach to foreign agents (e.g. bacteria), or harmful cells. Mepolizumab attaches to a naturally occurring body protein called ‘Interleukin 5’ and stops it from working. It is thought that this may help reduce severe asthma symptoms. Only participants who complete the last treatment visit for one of two previous studies (MEA115588 and MEA115575) will be invited to consent to this study. This is an open label study which means that both the study doctor and participant will know the treatment that the participant's receiving. There will be 14 visits to attend (one every 4 weeks) during which various tests, questionnaires, blood tests and lung tests will be carried out. Participants will receive an injection containing Mepolizumab under the skin of the upper arm or thigh (subcutaneously) every 4 weeks until week 52. During the study, participants may remain on their normal asthma medication. Changes to normal asthma medication can be made if required by the study doctor. Participants will be asked to attend a final safety visit 12 weeks after their last injection. At the end of the study participants should be prescribed appropriate alternative asthma therapy as determined by the study doctor.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  13/EM/0097

• Date of REC Opinion

  18 Mar 2013

• REC opinion

  Favourable Opinion