open to eligible people ages 18 years to 75 years
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm multicenter study to evaluate the efficacy and safety of rituximab compared with mycophenolate mofetil (MMF) in patients with moderate-to-severely active pemphigus vulgaris (PV) requiring 60-120 mg/day oral prednisone (or equivalent). Patients must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening. Approximately 124 patients will be enrolled at up to 60 centers worldwide. Patients will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness. The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.
Sacramento, California and other locations