Pemphigus Vulgaris Clinical Trial
Official title:
OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening
autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel
monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is
expressed only in B lymphocytes.
The purpose of this study was to evaluate the efficacy, tolerability, and safety of
ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered
once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week
0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in
the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg
(desmoglein) autoantibodies in PV, that clinical remission of the disease would result.
Novartis terminated the development of the PV program and this study was terminated for non-safety reasons ;
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