A longterm Safety study for asthmatic subjects

• Research type

  Research Study

• Full title

  A multi-centre, open-label, long term safety study of mepolizumab in asthmatic subjects who participated in the MEA112997 trial.

• IRAS ID

  111139

• Contact name

  Ian Pavord

• Eudract number

  2012-001643-51

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to explore longterm safety of mepolizumab and how well it works in people with severe asthma who have participated in a previous mepolizumab study. 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. In this open label study each subject will receive 100mg of Mepolizumab given by injection once monthly under the skin in the upper arm. Subjects will continue taking their normal asthma medication. The effects of mepolizumab, both good and bad, will be explored. Information about how the study drug affects the participant's body and their health will be collected through tests and procedures, throughout the study. Subjects will attend the clinic every 4 weeks. The study is expected to last around 112 weeks but it could be longer for suitable patients whilst mepolizumab remains in development but is not yet commercially available. There is a screening period to check eligiblity, treatment period and a follow-up visit after the last injection. Tests/procedures include ?½ Physical examination , medical history, heart monitoring ?½ Breathing test to measure lung function ?½ Vital signs: weight, height, blood pressure, temperature, pulse ?½ Blood tests to check general health, and other blood tests to measure indicators of asthma in the blood ?½ pregnancy tests for women who can become pregnant ?½ Asthma questionnaire Visits may take up to 2 hours or up to 3 hours following the first 3 dosing visits to include observation following the injection.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0284

• Date of REC Opinion

  17 Sep 2012

• REC opinion

  Further Information Favourable Opinion