Mepolizumab for the treatment of Severe Asthma

• Research type

  Research Study

• Full title

  MEA115588 A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe uncontrolled refractory asthma

• IRAS ID

  107529

• Contact name

  James Fettiplace

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2012-001251-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Severe asthma can be treated using high dose inhaled steroids, but many patients continue to have exacerbations (flare ups). This study, funded by GlaxoSmithKline, will test how effective a new medicine called mepolizumab is at treating severe asthma and in particular if it reduces the number of exacerbations. Mepolizumab is a monoclonal antibody, not yet approved for doctors to prescribe. Antibodies are molecules in blood and tissufluds 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.This study will compare two doses of mepolizumab and placebo (a medicine that looks like the study medicine but doesn??t contain the actual medicine), given by injection once monthly to participants with severe asthma who will continue taking their normal asthma medication throughout the study. There may be 13 visits to attend during which various tests, questionnaires and lung tests will be carried out. Every 4 weeks after the run in visit and until week 28, participants will receive two injections, one into a vein and one under the skin of the upper arm. In two thirds of participants, one of these injections will contain mepolizumab, and in the remainder both injections will contain placebo. At the end of the study, eligible participants may be invited to participate in an extension study where all participants will receive mepolizumab injection in the upper arm every 4 weeks. Participants who complete this study and enter the extension study will participate in this study for a minimum of 33 weeks. Participants who complete this study and do not enter the extension study will be followed up for an additional 8 weeks.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0286

• Date of REC Opinion

  20 Aug 2012

• REC opinion

  Further Information Favourable Opinion