NCT04140305
Recruiting
October 25, 2019
April 28, 2022
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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Administration of RPC-1063 Patients with relapsing MS will receive RPC-1063 orally: |
Drug: RPC-1063 Oral capsule |
Inclusion Criteria: Below are some criteria for inclusion. Additional Inclusion criteria apply. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. Subject is male or female 18 to 65 years of age (inclusive) at the time of signing of the ICF. Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria. Subjects has ≤ 5 years since time of RMS diagnosis. 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 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. 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. Subject has a visual or other sensorimotor impairment likely to confound test performance. Subject has a presence of > 10 GdE lesions on the Baseline brain MRI scan. Subject has a history of developmental disorder (eg, attention-deficit/hyperactivity disorder [ADHD], learning disability).
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 #.
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
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
Washington University School Medicine - CAM- Neuroscience Center
Saint Louis
United States, Missouri
The MS Center for Innovations in Care
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
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
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
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, 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
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, West Virginia
WVU Neurology
Morgantown
United States, Wisconsin
University of Wisconsin
Madison
United States, Wisconsin
Medical College of Wisconsin
Milwaukee
Canada, Ontario
Local Institution - 203
London
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
Celgene
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb