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

• ClinicalTrials.gov Identifier: NCT04140305
• Recruitment Status: Recruiting
• First Posted: October 25, 2019
• Last Update Posted: April 28, 2022
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: October 24, 2019
• First Posted Date: October 25, 2019
• Last Update Posted Date: April 28, 2022
• Actual Study Start Date: January 16, 2020
• Estimated Primary Completion Date: January 27, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 24, 2019)

• 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
• 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
• 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
• 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
• 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
• 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
• Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years [ Time Frame: Up to approximately 3 years ]
  Magnetic Resonance Imaging
• GdE lesion volume over 3 years [ Time Frame: Up to approximately 3 years ]
  Magnetic Resonance Imaging
• 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
• 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
• Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) [ Time Frame: Up to approximately 3 years ]
  Change is TSQM score over 3 years
• Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) [ Time Frame: Up to approximately 3 years ]
  Change in WPAI score over 3 years
• 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.
• 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
• 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
• Annualized relapse rate (ARR) [ Time Frame: Up to approximately 3 years ]
  Change in relapse rate over 3 years
• 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
• 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
• 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
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 all subjects who finish the subject and for those who discontinue, 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. 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

Drug: RPC-1063

Oral capsule

Other Name: Ozanimod

Study Arms

Experimental: Administration of RPC-1063

Patients with relapsing MS will receive RPC-1063 orally:

Intervention: Drug: RPC-1063

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 24, 2019): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 27, 2026
• Estimated Primary Completion Date: January 27, 2026 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

• Listed Location Countries: Canada, Puerto Rico, United States

Administrative Information

• NCT Number: NCT04140305
• Other Study ID Numbers: RPC-1063-MS-001; U1111-1240-5667 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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/

• Current Responsible Party: Celgene
• Original Responsible Party: Same as current
• Current Study Sponsor: Celgene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Celgene
• Verification Date: April 2022