Study Description

Brief summary:

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.

• Condition or Disease:Multiple Sclerosis
• Intervention/Treatment: Drug: RPC-1063
• Phase: Phase 3

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved) [ Time Frame: Up to approximately 3 years ]
  Symbol Digit Modalities Test
• Secondary Outcome Measures: 1. Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened) [ Time Frame: Up to approximately 3 years ]
  Symbol Digit Modalities Test
• Secondary Outcome Measures: 2. Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable) [ Time Frame: Up to approximately 3 years ]
  Symbol Digit Modalities Test
• Secondary Outcome Measures: 3. Proportion of subjects with an increase in raw score of ≥ 3 points from baseline [ Time Frame: Up to approximately 3 years ]
  Symbol Digit Modalities Test
• Secondary Outcome Measures: 4. Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline [ Time Frame: Up to approximately 3 years ]
  Symbol Digit Modalities Test
• Secondary Outcome Measures: 5. Change from baseline in Symbol Digit Modalities Test (SMDT) [ Time Frame: Up to approximately 3 years ]
  The SDMT is a measure of cognitive processing speed
• Secondary Outcome Measures: 6. Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes [ Time Frame: Up to approximately 3 years ]
  Magnetic resonance imaging (MRI) brain volume
• Secondary Outcome Measures: 7. Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years [ Time Frame: Up to approximately 3 years ]
  Magnetic Resonance Imaging
• Secondary Outcome Measures: 8. GdE lesion volume over 3 years [ Time Frame: Up to approximately 3 years ]
  Magnetic Resonance Imaging
• Secondary Outcome Measures: 9. Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3 [ Time Frame: Up to approximately 3 years ]
  Magnetic Resonance Imaging
• Secondary Outcome Measures: 10. Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3 [ Time Frame: Up to approximately 3 years ]
  Magnetic Resonance Imaging
• Secondary Outcome Measures: 11. Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) [ Time Frame: Up to approximately 3 years ]
  Change is TSQM score over 3 years
• Secondary Outcome Measures: 12. Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) [ Time Frame: Up to approximately 3 years ]
  Change in WPAI score over 3 years
• Secondary Outcome Measures: 13. Fatigue Severity Scale (FSS) [ Time Frame: Up to approximately 3 years ]
  The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.
• Secondary Outcome Measures: 14. Multiple Sclerosis Quality of Life-54 (MSQOL-54) [ Time Frame: Up to approximately 3 years ]
  The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument
• Secondary Outcome Measures: 15. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Up to approximately 3 years ]
  The HADS was developed to identify anxiety disorders and depression among subjects in nonpsychiatric hospital clinics
• Secondary Outcome Measures: 16. Annualized relapse rate (ARR) [ Time Frame: Up to approximately 3 years ]
  Change in relapse rate over 3 years
• Secondary Outcome Measures: 17. Timed 25-foot Walk (T25W) [ Time Frame: Up to approximately 3 years ]
  Disability progression assessed by 20% worsening from baseline over 3 years on T25W
• Secondary Outcome Measures: 18. Nine-hole Peg Test (9-HPT) [ Time Frame: Up to approximately 3 years ]
  Change from baseline in the time in seconds needed to complete test activity
• Secondary Outcome Measures: 19. Expanded Disability Status Scale (EDSS) [ Time Frame: Up to approximately 3 years ]
  Change from baseline in EDSS score (0-10) yearly and at 3 years
• Secondary Outcome Measures: 20. Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]
  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.

Eligibility Criteria

Information from the National Library of Medicine

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• Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT04140305 History of Changes
• Other Study ID Numbers: RPC-1063-MS-001, U1111-1240-5667
• First Posted: October 25, 2019 Key Record Dates
• Last Update Posted: April 7, 2020
• Last Verified: April 2020

• Individual Participant
  Data (IPD) Sharing
  Statement:

• Plan to Share IPD: Yes
• Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
• Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
• Time Frame: See Plan Description
• Access Criteria: See Plan Description
• URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Multiple Sclerosis
  RPC-1063 Ozanimod
• Additional relevant MeSH terms: Multiple Sclerosis Sclerosis