Relapsing-remitting multiple sclerosis (RRMS) is a type of multiple sclerosis in which patients have relapses or episodes of MS. Opicinumab is a monoclonal antibody that is known to enhance remyelination in patients with CNS demyelinating diseases. This study aims to evaluate the safety and efficacy of opicinumab in patients with RRMS.
This is a randomized, double-blind, placebo-controlled, dose-ranging, phase-2 study conducted in 72 sites across 12 countries. The study included a total of 419 patients aged 18-58 years with RRMS. The participants were randomized in a 1:2:2:2:2 ratio and were assigned to opicinumab 3 mg/kg, 10 mg/kg, 30 mg/kg, or 100 mg/kg, or placebo. The primary outcome of the study was disability improvement over 72 weeks.
Out of a total of 419 patients, 93 were assigned to placebo, 45 to opicinumab 3 mg, 95 to opicinumab 10 mg, 94 to opicinumab 30 mg, and 92 to opicinumab 100 mg. Disability improvement over 72 weeks was confirmed in 45 (49%) patients assigned to placebo, 21 (47%) assigned to opicinumab 3 mg, 59 (63%) to opicinumab 10 mg, 59 (65%) to opicinumab 30 mg, and 36 (40%) to opicinumab 100 mg.
The research concluded that opicinumab showed a significant confirmed disability improvement in patients with RMSS, but no dose-linear improvements were recorded.