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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/04/2020.

Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

Clinicaltrials.gov identifier NCT04140305

Recruitment Status Recruiting

First Posted October 25, 2019

Last update posted April 7, 2020

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
  • Study Type: Interventional
  • Estimated Enrollment: 250 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: October 2024
  • Estimated Study Completion Date: October 2024
Arms and interventions
Arm Intervention/treatment
Experimental: Administration of RPC-1063
Patients with relapsing MS will receive RPC-1063 orally:
Drug: RPC-1063
Oral capsule
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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 7. Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years [ Time Frame: Up to approximately 3 years ]
    Magnetic Resonance Imaging
  • 8. GdE lesion volume over 3 years [ Time Frame: Up to approximately 3 years ]
    Magnetic Resonance Imaging
  • 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
  • 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
  • 11. Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) [ Time Frame: Up to approximately 3 years ]
    Change is TSQM score over 3 years
  • 12. Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) [ Time Frame: Up to approximately 3 years ]
    Change in WPAI score over 3 years
  • 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.
  • 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
  • 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
  • 16. Annualized relapse rate (ARR) [ Time Frame: Up to approximately 3 years ]
    Change in relapse rate over 3 years
  • 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
  • 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
  • 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
  • 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
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Below are some criteria for inclusion. Additional Inclusion criteria apply.

1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to
any study-related assessments/procedures being conducted.

2. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.

3. Subject is male or female 18 to 65 years of age (inclusive) at the time of signing of
the ICF.

4. Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.

5. Subjects has ≤ 5 years since time of RMS diagnosis.

6. Subject has ≤ 1 approved RMS DMT at time of study entry.

Exclusion Criteria:

Following are some criteria that would exclude the subject from participation. Additional
exclusion criteria apply.

Exclusions Related to General Health

1. Subject has any clinically relevant hepatic, neurological, pulmonary,
ophthalmological, endocrine, psychiatric, or other major systemic disease making
implementation of the protocol or interpretation of the study difficult or that would
put the subject at risk by participating in the study. Subjects with mild or moderate
asthma, and subjects with other mild pulmonary disease (eg, chronic obstructive
pulmonary disease [COPD]) may be included in the study.

2. Subject has a presence of other neurologic disorders to explain the progressive
neurologic disability (as defined in the key inclusion criteria) or that might affect
cognition.

3. Subject has a visual or other sensorimotor impairment likely to confound test
performance.

4. Subject has a presence of > 10 GdE lesions on the Baseline brain MRI scan.

5. Subject has a history of developmental disorder (eg, attention-deficit/hyperactivity
disorder [ADHD], learning disability).

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 72 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Michael Connor, MD Celgene

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