Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

Summary

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record. The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

Timeline

Start

2013-12-03

Primary completion

2017-03-27

Completion

2017-04-13

Outcome

Met primary endpoint

registry analysis (superiority test); Interferon Beta-1a vs Ozanimod 1 mg; p <0.0001; Rate Ratio 0.623 (95% CI 0.506 to 0.768) NCT02047734 ↗

registry analysis (superiority test); Interferon Beta-1a vs Ozanimod 0.5 mg; p = 0.0167; Rate Ratio 0.791 (95% CI 0.652 to 0.958) NCT02047734 ↗

paper ozanimod was well tolerated and associated with a significantly lower rate of clinical relapses than intramuscular interferon beta-1a. PMID 31492652 ↗

Publications

• Results Cree B, et al. The RADIANCE and SUNBEAM phase 3 studies of ozanimod in relapsing multiple sclerosis: study design and baseline characteristics. Presented at the 69th Annual American Academy of Neurology Meeting, April 22-28, 2017, Boston, MA. Abstract No. P6-344
• Results Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021-1033. doi: 10.1016/S1474-4422(19)30238-8. Epub 2019 Sep 3.
• Harris S, Comi G, Cree BAC, Arnold DL, Steinman L, Sheffield JK, Maddux R, Southworth H, Kappos L, Cohen JA. Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials. Eur J Neurol. 2025 Jun;32(6):e70222. doi: 10.1111/ene.70222.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Interferon beta-1a	Protein / enzyme biologic	30 ug	Intramuscular
Subject	Ozanimod	Small molecule	0.5 mg	Oral
Subject	Ozanimod	Small molecule	1 mg	Oral

Indications