New Dug, Siponimod in Phase 3 Trial For Secondary Progressive Multiple Sclerosis
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Phase 3 trial will be held worldwide and is recruiting 1,530
individuals who have secondary progressive multiple sclerosis (SPMS) to
test the safety and effectiveness of an experimental oral therapy
siponimod (BAF312) manufactured by Novartis Pharmaceuticals AG versus an
inactive placebo. The drug, siponimod, is an immune system-modulating
treatment designed to be a more selective sphingosine 1-phosphate
receptor modulator than Gilenya (fingolimod, Novartis). Gilenya was
approved in 2010 for adults with relapsing forms of MS to decrease the
frequency of relapses to delay accumulation of physical disabilities.
In a Phase 2 trial, siponimod demonstrated safety and efficacy on MRI
scans in individuals with relapsing-remitting MS. Information on this
trial is available in The Lancet Neurology, Early Online Publication,
June 11, 2013 . Siponimod is believed to act by retaining specific
white blood cells in lymph nodes keeping then out of circulation and
from getting into the central nervous system. This oral drug can also
enter the central nervous system where it may have a direct
anti-inflammatory or neurobiological effect. The secondary progressive
multiple sclerosis (SPMS) study is currently recruiting participants and
is sponsored by Novartis Pharmaceuticals under clinical trial
identifier NCT01665144. The purpose of this phase 3 trial is to
evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in
a variable treatment duration in patients with SPMS. Patients will be
randomized to receive Siponimod (BAF312) for a duration of 23 to 42
months with a maximum of 60 months. Patients who meet all inclusion and
none of the exclusion criteria will be treated with BAF312 daily.
Eligibility age runs 18 to 60 years and will include both sexes.
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Labels: Gilenya
