Mepolizumab Phase III Study Started In EGPA Patients
GlaxoSmithKline has reported the start of a Phase III study to evaluate the efficacy and safety of mepolizumab, an investigational interleukin-5 (IL-5) antagonist, in patients with eosinophilic granulomatosis with polyangiitis (EGPA).
The pivotal Phase III study, MEA115921, is a randomised, double-blind study with the purpose to investigate the efficacy and safety of a 300mg dose of mepolizumab (administered subcutaneously every four weeks) compared with placebo over a 52-week study treatment period in patients with relapsing or refractory EGPA receiving standard-of-care therapy including background corticosteroid therapy with or without immunosuppressive therapy.
The study is being conducted as part of an agreement between GSK and the National Institute of Allergy and Infectious Diseases. Through this collaboration the mechanisms that underlie EGPA will also be investigated, with potential future benefits for patients.