Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
Phase 2/Phase 3
This study is a two-part trial consisting of Part A (presented in this record) and Part B
The primary objective in Part A of this study was to demonstrate the superior efficacy of
ozanimod compared to placebo by showing a reduction in the cumulative number of total
gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing
multiple sclerosis (RMS).
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
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).
Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Active, not recruiting
This is an open-label, multicenter, extension trial to evaluate the long-term safety and
efficacy of RPC1063 in patients with moderately to severely active ulcerative colitis (UC).
The purpose of this extension trial is to evaluate the long-term safety and efficacy of
RPC1063 in patients with moderately to severely active ulcerative colitis (UC).
Only those patients who have previously participated in a trial of RPC1063, being either
RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be
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