1. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study
- Author
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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, and Investigators, for the RADIANCE Trial
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Neurosciences ,Multiple Sclerosis ,Brain Disorders ,Clinical Research ,Neurodegenerative ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adolescent ,Adult ,Double-Blind Method ,Female ,Humans ,Indans ,Magnetic Resonance Imaging ,Male ,Middle Aged ,Multiple Sclerosis ,Relapsing-Remitting ,Outcome Assessment ,Health Care ,Oxadiazoles ,Sphingosine 1 Phosphate Receptor Modulators ,Young Adult ,Clinical trial ,disease-modifying therapies ,MRI ,relapsing ,remitting ,T2 lesions ,multiple sclerosis ,RADIANCE Trial Investigators ,relapsing/remitting ,Neurology & Neurosurgery ,Clinical sciences ,Biological psychology - Abstract
BackgroundOzanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5.ObjectiveEvaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis.MethodsIn 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).ResultsA 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.ConclusionOzanimod 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.
- Published
- 2019