This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years. All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of ≥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For subjects who discontinue the study, there will be a 30-day (± 15 days) and a 90-day (± 10 days) Safety Follow-up Visit. There is no planned protocol extension following the end of the study. If commercial drug is not available at the end of the study, subjects may be started on another medication as determined by their individual treating physician. Approximately 250 subjects with RMS will be recruited for this study. Subjects with RMS will be enrolled in this study if they have received ≤1 DMT, have an EDSS ≤ 3.5, and have been diagnosed with RMS within 5 years of study entry. The Investigator will be responsible for the overall conduct of the study at the site, confirmation of subject eligibility, routine study subject clinical management including for MS relapses, and management of AEs.
Name: RPC-1063
Description: Symbol Digit Modalities Test
Measure: Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved) Time: Up to approximately 3 yearsDescription: Symbol Digit Modalities Test
Measure: Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened) Time: Up to approximately 3 yearsDescription: Symbol Digit Modalities Test
Measure: Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable) Time: Up to approximately 3 yearsDescription: Symbol Digit Modalities Test
Measure: Proportion of subjects with an increase in raw score of ≥ 3 points from baseline Time: Up to approximately 3 yearsDescription: Symbol Digit Modalities Test
Measure: Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline Time: Up to approximately 3 yearsDescription: The SDMT is a measure of cognitive processing speed
Measure: Change from baseline in Symbol Digit Modalities Test (SMDT) Time: Up to approximately 3 yearsDescription: Magnetic resonance imaging (MRI) brain volume
Measure: Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes Time: Up to approximately 3 yearsDescription: Magnetic Resonance Imaging
Measure: Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years Time: Up to approximately 3 yearsDescription: Magnetic Resonance Imaging
Measure: GdE lesion volume over 3 years Time: Up to approximately 3 yearsDescription: Magnetic Resonance Imaging
Measure: Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3 Time: Up to approximately 3 yearsDescription: Magnetic Resonance Imaging
Measure: Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3 Time: Up to approximately 3 yearsDescription: Change is TSQM score over 3 years
Measure: Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) Time: Up to approximately 3 yearsDescription: Change in WPAI score over 3 years
Measure: Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) Time: Up to approximately 3 yearsDescription: The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.
Measure: Fatigue Severity Scale (FSS) Time: Up to approximately 3 yearsDescription: The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument
Measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54) Time: Up to approximately 3 yearsDescription: The HADS was developed to identify anxiety disorders and depression among subjects in nonpsychiatric hospital clinics
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Up to approximately 3 yearsDescription: Change in relapse rate over 3 years
Measure: Annualized relapse rate (ARR) Time: Up to approximately 3 yearsDescription: Disability progression assessed by 20% worsening from baseline over 3 years on T25W
Measure: Timed 25-foot Walk (T25W) Time: Up to approximately 3 yearsDescription: Change from baseline in the time in seconds needed to complete test activity
Measure: Nine-hole Peg Test (9-HPT) Time: Up to approximately 3 yearsDescription: Change from baseline in EDSS score (0-10) yearly and at 3 years
Measure: Expanded Disability Status Scale (EDSS) Time: Up to approximately 3 yearsDescription: An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Measure: Adverse Events (AEs) Time: Up to approximately 3 yearsAllocation: N/A
Single Group Assignment
There is one SNP
Timed 25-foot Walk (T25W). --- T25W ---
Disability progression assessed by 20% worsening from baseline over 3 years on T25W. --- T25W ---