Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study

Jeffrey A. Cohen, Giancarlo Comi, Douglas L. Arnold, Amit Bar-Or, Krzysztof W. Selmaj, Lawrence Steinman, Eva K. Havrdová, Bruce A.C. Cree, Xavier Montalbán, Hans Peter Hartung, Vivian Huang, Paul Frohna, Brett E. Skolnick, Ludwig Kappos

Research output: Contribution to journalArticleResearch

15 Citations (Scopus)

Abstract

© The Author(s), 2018. Background: Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Objective: Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. Methods: In the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomized (1:1:1) to once-daily ozanimod hydrochloride (0.5 or 1 mg) or placebo. After 24 weeks, participants could enter a 2-year, dose-blinded extension. Ozanimod-treated participants continued their assigned dose; placebo participants were re-randomized (1:1) to ozanimod hydrochloride 0.5 or 1 mg (equivalent to ozanimod 0.46 and 0.92 mg). Results: A total of 223 (89.6%) of the 249 participants completed the blinded extension. At 2 years of the extension, the percentage of participants who were gadolinium-enhancing lesion-free ranged from 86.5% to 94.6%. Unadjusted annualized relapse rate during the blinded extension (week 24—end of treatment) was 0.32 for ozanimod hydrochloride 0.5 mg → ozanimod hydrochloride 0.5 mg, 0.18 for ozanimod hydrochloride 1 mg → ozanimod hydrochloride 1 mg, 0.30 for placebo → ozanimod hydrochloride 0.5 mg, and 0.18 for placebo → ozanimod hydrochloride 1 mg. No second-degree or higher atrioventricular block or serious opportunistic infection was reported. Conclusion: Ozanimod demonstrated sustained efficacy in participants continuing treatment up to 2 years and reached similar efficacy in participants who switched from placebo; no unexpected safety signals emerged.
Original languageEnglish
Pages (from-to)1255-1262
JournalMultiple Sclerosis Journal
Volume25
DOIs
Publication statusPublished - 1 Aug 2019

Keywords

  • Clinical trial
  • MRI
  • T2 lesions
  • disease-modifying therapies
  • multiple sclerosis
  • relapsing/remitting

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