GSK begins Phase III study of subcutaneous Ofatumumab to treat pemphigus vulgaris

4th July 2013 (Last Updated July 4th, 2013 18:30)

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.

pemphigus vulgaris

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.

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.

Objectives of the study are to determine the efficacy and safety of subcutaneous ofatumumab in pemphigus vulgaris, based on disease remission.


Image: Micrograph of pemphigus vulgaris with the characteristic 'tombstoning'. H&E stain. Photo: courtesy of Nephron.