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

  • Author(s): Cohen, Jeffrey A
  • Comi, Giancarlo
  • Arnold, Douglas L
  • Bar-Or, Amit
  • Selmaj, Krzysztof W
  • Steinman, Lawrence
  • Havrdová, Eva K
  • Cree, Bruce Ac
  • Montalbán, Xavier
  • Hartung, Hans-Peter
  • Huang, Vivian
  • Frohna, Paul
  • Skolnick, Brett E
  • Kappos, Ludwig
  • RADIANCE Trial Investigators
  • et al.
Abstract

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.

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