Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial

Publication date: Available online 3 September 2019Source: The Lancet NeurologyAuthor(s): Giancarlo Comi, Ludwig Kappos, Krzysztof W Selmaj, Amit Bar-Or, Douglas L Arnold, Lawrence Steinman, Hans-Peter Hartung, Xavier Montalban, Eva Kubala Havrdová, Bruce A C Cree, James K Sheffield, Neil Minton, Kartik Raghupathi, Ning Ding, Jeffrey A Cohen, SUNBEAM Study InvestigatorsSummaryBackgroundOzanimod, a sphingosine 1-phosphate receptor modulator, selectively binds to receptor subtypes 1 and 5 with high affinity. The RADIANCE phase 2 study showed that ozanimod had better efficacy than placebo on MRI measures, with a favourable safety profile, in participants with relapsing multiple sclerosis. The SUNBEAM study aimed to assess the safety and efficacy of ozanimod versus intramuscular interferon beta-1a in participants with relapsing multiple sclerosis.MethodsSUNBEAM was a randomised, double-blind, double-dummy, active-controlled phase 3 trial done at 152 academic medical centres and clinical practices in 20 countries. We enrolled participants aged 18–55 years with relapsing multiple sclerosis, baseline expanded disability status scale (EDSS) score of 0·0–5·0, and either at least one relapse within the 12 months before screening or at least one relapse within 24 months plus at least one gadolinium-enhancing lesion within 12 months before screening. Participants were randomly assigned 1:1:1 by a blocked algorithm stratified by country and baseline EDSS score to at least 12 months...
Source: The Lancet Neurology - Category: Neurology Source Type: research