Date: 2016-03-08
Type of
information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: GSK (UK)
Product: ofatumumab
Action
mechanism:
- monoclonal antibody. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006).
Disease: pemphigus vulgaris
Therapeutic
area: Autoimmune diseases - Dermatological diseases
Country:
Trial
details:
- 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 GSK.
Latest
news:
- • On March 8, 2016, Genmab announced an update on development plans for ofatumumab in autoimmune indications following the transfer of the rights to ofatumumab in this disease area from GSK to Novartis at the end of 2015. Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation of ofatumumab as therapy for patients with relapsing multiple sclerosis during the second half of 2016. The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK will be discontinued to focus on relapsing multiple sclerosis. The decision to discontinue the trial was not related to any safety or tolerability concerns. There are no current plans to develop ofatumumab in neuromyelitis optica.
- • On July 4, 2013, Genmab has announced that GSK will start a new Phase III study of ofatumumab given subcutaneously to treat pemphigus vulgaris, a rare autoimmune disorder of the skin Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GSK. Under the companies' agreement, GSK is responsible for development of ofatumumab in autoimmune indications and related costs.
Is
general: Yes
