Mepolizumab in subjects who require daily oral corticosteroids

• Research type

  Research Study

• Full title

  MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma

• IRAS ID

  110514

• Contact name

  I Pavord

• Eudract number

  2012-001497-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Patients with severe asthma require treatment with large doses of corticosteroids to control their disease. Corticosteroids can be effective, but regular use can sometimes result in harmful side effects. This study funded by GlaxoSmithKline, will test how effective a new medicine called mepolizumab is at treating severe asthma by gradually and safely reducing the amount of steroid pills used during the study so that only the minimum amount required is used. Mepolizumab is a monoclonal antibody, not yet approved for doctors to prescribe. Antibodies are molecules in blood and tissufluds that help fight infection. 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. This study will compare mepolizumab and placebo (a placebo looks like the study medicine but doesn??t contain the actual medicine) in participants with severe asthma who will continue taking their normal asthma medication throughout the study. There may be 11 visits to attend during which various tests, questionnaires and lung tests will be carried out. The first part of the study will help decide what the lowest dose of steroid pill should be. Then participants will receive either mepolizumab or placebo injection every 4 weeks under the skin of the upper arm. Four weeks after the first injection, the steroid dose will be gradually reduced and reduced further every 4 weeks if appropriate until week 20. At the end of the study, eligible participants may be invited to participate in an extension study where all participants will receive mepolizumab injection. Participants who complete this study and enter the extension study will participate in this study for a minimum of 27 weeks. Participants who complete this study and do not enter the extension study will participate in the study for 35 weeks.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0285

• Date of REC Opinion

  13 Sep 2012

• REC opinion

  Further Information Favourable Opinion