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Genmab A/S Collaborator Glaxosmithkline Plc Starts New Ofatumumab Phase III Study In Rare Skin Disorder-DJ


Thursday, 4 Jul 2013 01:42am EDT 

Dow Jones reported that Genmab A/S announced that Glaxosmithkline Plc will start a new Phase III study of ofatumumab given subcutaneously to treat pemphigus vulgaris, a rare autoimmune disorder of the skin. The study is double blinded and will include approximately 136 patients with active pemphigus vulgaris who have achieved disease control on a stable dose of steroids prior to randomization. Patients in this study will be randomized equally into one of two arms. Patients will receive either ofatumumab (60 mg) or placebo every 12 weeks for a total of five doses over which time a scheduled gradual steroid reduction will be undertaken. Patients will then be followed for at least 12 weeks longer. The study objectives are to establish the efficacy and safety of subcutaneous ofatumumab in pemphigus vulgaris, based on disease remission. This study is being conducted by GlaxoSmithKline Plc. In the pivotal trial on which approval for chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab was based (total population n=154), the most common adverse reactions (>=10%, all grades) to ofatumumab were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnoea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia.