Genmab collaborator GlaxoSmithKline (GSK) has commenced the third phase of its study of subcutaneous formulation of ofatumumab, a human monoclonal antibody, to treat an autoimmune skin disorder, pemphigus vulgaris.
Under a co-development and commercialisation agreement between Genmab and GSK, Ofatumumab is designed to target an epitope on the CD20 molecule around parts of the small and large extracellular loops.
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Genmab chief executive officer Dr Jan van de Winkel said: "We are pleased that GSK is investigating ofatumumab in the treatment of pemphigus vulgaris, a seriously debilitating and sometimes life-threatening autoimmune disease."
The double blinded study is expected to recruit around 136 active pemphigus vulgaris patients, whose disease was controlled on a stable dose of steroids prior to randomisation.
Study subjects will be randomised in 1:1 ratio with either ofatumumab 60mg or placebo every 12 weeks for a total of five doses, during which a scheduled gradual steroid reduction will be undertaken, and then observed for a minimum of 12 weeks.
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Objectives of the study are to determine the efficacy and safety of subcutaneous ofatumumab in pemphigus vulgaris, based on disease remission.
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By GlobalDataImage: Micrograph of pemphigus vulgaris with the characteristic ‘tombstoning’. H&E stain. Photo: courtesy of Nephron.
