Phase 3 N=1,346 Randomized Quadruple-blind Treatment

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT02294058 ↗

Enrolled (actual)

1,346

Serious AEs

3.0%

Results posted

Nov 2020

Primary outcome: Primary: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period — 0.350; 0.241; 0.181 relapses/year — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ozanimod (Drug); Interferon beta-1a (Drug); Placebo to ozanimod (Drug); Placebo to interferon beta-1a (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Celgene
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Annualized Relapse Rate (ARR) During the Treatment Period	0.350; 0.241; 0.181	<0.0001 sig
SECONDARY Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months	2.836; 2.139; 1.465	<0.0001 sig
SECONDARY Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12	0.433; 0.287; 0.160	<0.0001 sig
SECONDARY Time to Onset of Disability Progression Confirmed After 3 Months	NA; NA; NA	0.3055
SECONDARY Time to Onset of Disability Progression Confirmed After 6 Months	NA; NA; NA	0.6725
SECONDARY Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12	63.17; 68.29; 74.05	0.0006 sig
SECONDARY Percentage of Participants Who Were T2 Lesion-Free at Month 12	23.44; 26.39; 27.96	0.1180
SECONDARY Percent Change From Baseline in Normalized Brain Volume at Month 12	-0.57; -0.50; -0.39	<0.0001 sig
SECONDARY Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test	-0.022; -0.007; 0.003	0.1290
SECONDARY Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores	0.046; 1.414; 1.925; -0.123; 0.283; 0.260	0.0364 sig
SECONDARY Number of Participants With Treatment Emergent Adverse Events	336; 259; 268; 182; 113; 138	—

Summary

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

Eligibility Criteria

Inclusion Criteria

Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
EDSS score between 0 and 5.0 at baseline

Exclusion Criteria

Primary progressive multiple sclerosis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02294058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.