Efficacy and safety of mepolizumab in refractory asthma

• Research type

  Research Study

• Full title

  A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma.

• IRAS ID

  29831

• Contact name

  Ian D Pavord

• Eudract number

  2009-014415-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to test the safety of a new medicine called mepolizumab and how well it works in people with severe asthma. Mepolizumab is a humanised monoclonal antibody, currently not approved for prescription to patients with severe asthma. Antibodies are molecules in blood and tissufluds that help fight infection. They recognise and attach to foreign agents (e.g. bacteria), foreign substances, or harmful cells. Monoclonal antibodies can be obtained from cells grown in the laboratory and are very specific for their intended targets. Mepolizumab attaches to a naturally occurring protein in the body called ??Interleukin 5?? and stops it working. This may help to reduce severe asthma symptoms. This study will compare three different doses of Mepolizumab and a placebo (a medicine that looks like the study medicine but doesn??t contain the actual medicine), given by injection once monthly to participants who will continue taking their normal asthma medication. Three groups of people will receive different strengths of Mepolizumab and another group will receive the. The effects of mepolizumab, both good and bad, will be compared to effects seen in people who are not taking it. The study doctor and the people taking part won??t know which group is getting which treatment. This way, the findings from the groups will be handled in the same way. A computer will put people into groups by chance. Participants will have an equal chance of being placed in any of the four groups. Information about how the study drug affects the participant's body and their health will be collected through tests and procedures, including lung function tests, blood tests and questionnaires, conducted at 17 scheduled clinic visits. This study will last about 58 weeks, including follow-up after the last injection.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/8

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Favourable Opinion