Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that
specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which
expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid
immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that
targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse
rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both
well tolerated and efficacious in several indications, including a small, placebo-controlled
trial in RRMS using an intravenous (IV) formulation.
This double-blind, placebo-controlled, parallel-group study will investigate the safety and
efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS.
The primary objective of the study is to investigate the efficacy as assessed by magnetic
resonance imaging. Other objectives will include evaluation of tolerability/safety,
dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as
other clinical endpoints.