Arzerra enters Phase III study for Pemphigus Vulgaris- Stiefel/GSK

Stiefel/GSK has announced the start of a Phase III study to evaluate the efficacy and safety of subcutaneous ofatumumab (Arzerra) in patients with Pemphigus Vulgaris, a rare autoimmune skin disorder. The global study will assess disease remission in patients with Pemphigus Vulgaris treated with subcutaneous ofatumumab as add-on treatment to oral steroids, the global standard-of-care. This global, multicentre, randomised, double-blind, placebo-controlled, parallel-group study (OPV116910) will assess the efficacy, safety, and tolerability of subcutaneous ofatumumab in subjects with Pemphigus Vulgaris. The primary objective of the study is to determine disease remission, following treatment with subcutaneous ofatumumab as add-on treatment to oral steroids (which will gradually be reduced) compared to a control arm receiving placebo as add-on treatment.

Subcutaneous ofatumumab will be administered at a dose of 20 mg every four weeks (following two initial loading doses) for a total of 56 weeks. Secondary objectives include evaluation of safety, tolerability, B-cell depletion and repletion, anti-desmoglein antibody levels, immunogenicity, pharmacokinetics, and other clinical and quality of life endpoints.