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news.GlaxoSmithKline (GSK), Genmab's collaborator, has commenced a new Phase III study with subcutaneous formulation of ofatumumab to treat patients with pemphigus vulgaris, a rare autoimmune disorder of the skin.
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Developed under a co-development and commercialization agreement between Genmab and GSK, Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops.
Conducted by GSK, the study is double blinded that involves randomizing about 136 patients with active pemphigus vulgaris who have achieved disease control on a stable dose of steroids.
Genmab CEO Dr Jan van de Winkel said, "We are pleased that GSK are investigating ofatumumab in the treatment of pemphigus vulgaris, a seriously debilitating and sometimes life-threatening autoimmune disease."
In this study, patients involved will be randomized equally into one of two arms with either 60mg of ofatumumab or placebo for every 12 weeks in five doses.
Patients will then be placed under observation for at least 12 weeks.
The objectives of the Phase III study are to demonstrate efficacy and safety of subcutaneous ofatumumab in pemphigus vulgaris, depending on the disease remission.