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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

    September 27, 2021

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 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.

  • 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: June 2025

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

United States, Alabama
Neurological Institute of Alabama
Birmingham

United States, Alabama
North Carolina Neurology Association P.C
Cullman

United States, Alabama
University of South Alabama
Mobile

United States, Arizona
Multiple Sclerosis Center of Arizona
Phoenix

United States, California
Multiple Sclerosis Center of California
Laguna Hills

United States, California
SC3 Research - Pasadena
Pasadena

United States, California
UC Davis Medical Center
Sacramento

United States, Colorado
University of Colorado, School of Medicine - Hepatology Clinic - Anschutz
Aurora

United States, Colorado
Colorado Springs Neurological Associates
Colorado Springs

United States, Colorado
Advanced Neurosciences Research, LLC
Fort Collins

United States, District of Columbia
Georgetown University Hospital
Washington

United States, Florida
Neurology Offices of South Florida
Boca Raton

United States, Florida
Vero Beach Neurology and Research Institute
Vero Beach

United States, Georgia
Meridian Clinical Research, LLC - Savannah
Savannah

United States, Illinois
Northwest Neurology, Ltd
Hoffman Estates

United States, Illinois
Consultants In Neurology
Northbrook

United States, Indiana
Fort Wayne Neurological Center
Fort Wayne

United States, Iowa
Acellacare US Inc
Ames

United States, Kansas
University of Kansas Medical Center
Kansas City

United States, Louisiana
NeuroMedical Clinic of Central Louisiana
Alexandria

United States, Michigan
Detroit Medical Center
Detroit

United States, Michigan
Henry Ford Health System
Detroit

United States, Missouri
Washington University School Medicine - CAM- Neuroscience Center
Saint Louis

United States, Missouri
The MS Center for Innovations in Care
Saint Louis

United States, Montana
Advanced Neurology Specialists
Great Falls

United States, New Jersey
South Jersey MS Center
Audubon

United States, New Jersey
Holy Name Hospital
Teaneck

United States, New York
Dent Neurologic Institute
Amherst

United States, New York
UBMD Neurology
Buffalo

United States, New York
Stony Brook Neurosciences Institute - Neurology Associates of Stony Brook
East Setauket

United States, New York
NYU Langone Medical Center
New York

United States, New York
Weill Cornell Medical College
New York

United States, New York
South Shore Neurology Associates, Inc
Patchogue

United States, North Carolina
University of North Carolina
Chapel Hill

United States, North Carolina
Guilford Neurologic Research, PA
Greensboro

United States, North Carolina
Lake Norman Neurology
Mooresville

United States, North Carolina
Raleigh Neurology Associates PA
Raleigh

United States, Ohio
University of Cincinnati - Gardner Neuroscience Institute
Cincinnati

United States, Ohio
University Hospitals of Cleveland
Cleveland

United States, Ohio
UC Health, LLC
Dayton

United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City

United States, Pennsylvania
Thomas Jefferson University
Philadelphia

United States, Pennsylvania
Temple University - Lewis Katz School of Medicine
Philadelphia

United States, Pennsylvania
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh

United States, Tennessee
Advanced Neurosciences Institute
Franklin

United States, Tennessee
Hope Neurology MS Center
Knoxville

United States, Texas
Baylor Research Institute - Dallas Clinical Trials Office
Dallas

United States, Texas
Central Texas Neurology Consultants PA
Round Rock

United States, Texas
Neurology Center of San Antonio
San Antonio

United States, Virginia
Meridian Clinical Research, LLC - Norfolk
Norfolk

United States, Washington
Evergreen Hospital Muiltiple Sclerosis Center
Kirkland

United States, Washington
Virginia Mason Medical Center
Seattle

United States, Washington
Inland Northwest Research
Spokane

United States, Washington
MultiCare Institute for Research and Innovation
Tacoma

United States, West Virginia
Marshall University School of Medicine
Huntington

United States, West Virginia
WVU Neurology
Morgantown

United States, Wisconsin
University of Wisconsin
Madison

United States, Wisconsin
Medical College of Wisconsin
Milwaukee

Canada, Ontario
London Health Sciences Centre
London

Canada, Ontario
Ottawa Hospital
Ottawa

Canada, Ontario
St. Michael's Hospital
Toronto

Canada, Quebec
Universite de Montreal
Montreal

Canada
Maritime Neurology
Halifax

Puerto Rico
San Juan MS Center
Guaynabo

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: September 27, 2021
  • Last Verified: September 2021
  • 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: Phase 3b
    Ozanimod
    RPC-1063
    Multiple Sclerosis
  • Additional relevant MeSH terms: Sclerosis Multiple Sclerosis