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Recruiting phase III trial in secondary progressive MS with oral compound siponimod

A new clinical trial is underway for individuals who have secondary progressive multiple sclerosis (SPMS). The oral drug, siponimod, is an immune-modulating treatment designed to be a more selective sphingosine 1-phosphate (S1P) receptor modulator than Gilenya. Siponimod acts by retaining specific white blood cells (lymphocytes) in lymph nodes keeping then out of circulation and from getting into the central nervous system (CNS). This oral drug can also enter the central nervous system where it may have a direct anti-inflammatory and/or neurobiological effect. If effective at reducing compartmentalized CNS inflammation and/or other disease processes in SPMS, siponimod would represent the first oral treatment that targets the progressive component in SPMS.

The global Phase III trial named EXPAND is recruiting 1,530 SPMS patients in more than 30 countries to test the safety and efficacy of siponimod. About one-third of these participants (determined randomly, however neither the participant nor treating doctor will know which treatment is being received) will receive placebo and two-thirds will receive siponimod for a duration of 23 to 42 months with a maximum of 60 months.

The primary outcome will look at the delay in confirmed disability progression as measured by the Expanded Disability Status Scale. This well established scale is based on the presence of certain symptoms in a typical neurological exam. Secondary outcomes include disease activity as observed on MRI scans, scales that measure mobility, relapse rates, adverse events and abnormalities on lab tests.

Five sites in Australia (three in Sydney and two in Melbourne) are involved in this Phase III trial and are actively looking for patients.

New therapies, that are effective in delaying disability progression in patients with SPMS, are an important unmet medical need. The EXPAND study will explore the potential of siponimod in SPMS and help advance the knowledge of SPMS pathophysiology.

For more details on this trial and other trials recruiting patients in Australia and New Zealand visit www.mstrials.org.au

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Recruiting phase III trial in secondary progressive MS with oral compound siponimod