Mepolizumab in Phase III trials for COPD-GSK

GlaxoSmithKline has started a Phase III programme to evaluate the efficacy and safety of mepolizumab as an adjunctive therapy for adults who have severe Chronic Obstructive Pulmonary Disease (COPD). The programme will enrol approximately 1500 patients who are at high risk of COPD exacerbations despite the use of standard background therapy. Examination of COPD patient phenotypes has shown that an eosinophil (a type of white blood cell) predominant phenotype exists that is associated with an increased risk of exacerbations.

The programme consists of two pivotal studies (117113 and 117106) that together will integrate dose-ranging and long-term efficacy and safety evaluations. Each study uses a 52-week multi-centre, randomised, placebo controlled, double-blind, parallel group design. The primary endpoint in both is the frequency of moderate/severe exacerbations. Study 117113, will randomise patients to either mepolizumab 100mg subcutaneous (SC), mepolizumab 300mg SC or placebo, administered every four weeks. All patients will be required to have a blood eosinophil count above a pre-specified threshold to be eligible for this study. Study 117106 will randomise patients to mepolizumab 100mg SC or placebo administered every four weeks. Patients in both studies will continue on baseline standard of care COPD medications throughout the entire duration of the study.