Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
NCT ID: NCT04140305
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
188 participants
INTERVENTIONAL
2020-01-16
2025-05-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of RPC-1063
Patients with relapsing MS will receive RPC-1063 orally:
RPC-1063
Oral capsule
Interventions
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RPC-1063
Oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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).
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 123
Birmingham, Alabama, United States
Local Institution - 136
Cullman, Alabama, United States
Local Institution - 153
Mobile, Alabama, United States
Local Institution - 162
Phoenix, Arizona, United States
Local Institution - 128
Pasadena, California, United States
Local Institution - 164
Sacramento, California, United States
Local Institution - 107
Aurora, Colorado, United States
Local Institution - 102
Colorado Springs, Colorado, United States
Local Institution - 144
Fort Collins, Colorado, United States
Local Institution - 109
Washington D.C., District of Columbia, United States
Local Institution - 140
Boca Raton, Florida, United States
Local Institution - 158
Vero Beach, Florida, United States
Local Institution - 114
Savannah, Georgia, United States
Northwest Neurology, Ltd
Hoffman Estates, Illinois, United States
Local Institution - 108
Northbrook, Illinois, United States
Local Institution - 148
Fort Wayne, Indiana, United States
Local Institution - 126
Ames, Iowa, United States
Local Institution - 173
Kansas City, Kansas, United States
Local Institution - 133
Alexandria, Louisiana, United States
Local Institution - 152
Detroit, Michigan, United States
Local Institution - 112
Detroit, Michigan, United States
Local Institution - 122
St Louis, Missouri, United States
Local Institution - 143
St Louis, Missouri, United States
Advanced Neurology Specialists
Great Falls, Montana, United States
Local Institution - 149
Teaneck, New Jersey, United States
Dent Neurologic Institute
Amherst, New York, United States
Local Institution - 137
Buffalo, New York, United States
Local Institution - 160
East Setauket, New York, United States
Local Institution - 130
New York, New York, United States
Local Institution - 121
New York, New York, United States
Local Institution - 146
Patchogue, New York, United States
Local Institution - 131
Chapel Hill, North Carolina, United States
Local Institution - 106
Greensboro, North Carolina, United States
Local Institution - 170
Mooresville, North Carolina, United States
Raleigh Neurology Associates PA
Raleigh, North Carolina, United States
Local Institution - 174
Cincinnati, Ohio, United States
Local Institution - 171
Cleveland, Ohio, United States
Local Institution - 142
Dayton, Ohio, United States
Local Institution - 157
Oklahoma City, Oklahoma, United States
Local Institution - 159
Philadelphia, Pennsylvania, United States
Local Institution - 169
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Local Institution - 125
Franklin, Tennessee, United States
Local Institution - 119
Knoxville, Tennessee, United States
Local Institution - 139
Dallas, Texas, United States
Local Institution - 113
Round Rock, Texas, United States
Local Institution - 101
San Antonio, Texas, United States
Local Institution - 103
Norfolk, Virginia, United States
Local Institution - 141
Kirkland, Washington, United States
Local Institution - 168
Seattle, Washington, United States
Local Institution - 172
Spokane, Washington, United States
Local Institution - 124
Tacoma, Washington, United States
Local Institution - 156
Huntington, West Virginia, United States
Local Institution - 150
Morgantown, West Virginia, United States
Local Institution - 167
Madison, Wisconsin, United States
Local Institution - 147
Milwaukee, Wisconsin, United States
Local Institution - 203
London, Ontario, Canada
Local Institution - 204
Ottawa, Ontario, Canada
Local Institution - 206
Montreal, Quebec, Canada
Local Institution - 207
Halifax, , Canada
Local Institution - 166
Guaynabo, , Puerto Rico
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1240-5667
Identifier Type: OTHER
Identifier Source: secondary_id
RPC-1063-MS-001
Identifier Type: -
Identifier Source: org_study_id
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