Date: 2016-06-02
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Novartis (Switzerland)
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. The drug has been developed under a co-development and commercialization agreement between Genmab and GSK. In April 2014, Novartis has agreed to acquire GSK oncology productsincluding ofatumumab.
Disease: relapsing multiple sclerosis
Therapeutic area: Neurodegenerative diseases
Country: Puerto Rico, USA
Trial
details: Asclepios I is a randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis. ( NCT02792218)
Latest
news: * On June 2, 2016, Genmab announced that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016. The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the studies will shortly become available on clinicaltrials.gov.
The ASCLEPIOS I and II studies are randomized, double-blind, double-dummy studies comparing the efficacy and safety of subcutaneous ofatumumab versus teriflunomide, a standard treatment in MS, in approximately 900 patients with relapsing MS per study. Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks or of teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo). The primary endpoint of the studies is annualized relapse rate (ARR), which is the number of confirmed relapses in a 12 month period. The studies will be conducted by Novartis.
