Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
- Registration Number
- NCT04140305
- Lead Sponsor
- Celgene
- 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 available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
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.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of RPC-1063 RPC-1063 Patients with relapsing MS will receive RPC-1063 orally:
- Primary Outcome Measures
Name Time Method Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved) Up to approximately 3 years Symbol Digit Modalities Test
- Secondary Outcome Measures
Name Time Method Change from baseline in Symbol Digit Modalities Test (SMDT) Up to approximately 3 years The SDMT is a measure of cognitive processing speed
Multiple Sclerosis Quality of Life-54 (MSQOL-54) 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) 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) Up to approximately 3 years Change in relapse rate over 3 years
Timed 25-foot Walk (T25W) Up to approximately 3 years Disability progression assessed by 20% worsening from baseline over 3 years on T25W
Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened) Up to approximately 3 years Symbol Digit Modalities Test
Proportion of subjects with an increase in raw score of ≥ 3 points from baseline 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) Up to approximately 3 years Symbol Digit Modalities Test
Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline Up to approximately 3 years Symbol Digit Modalities Test
Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes Up to approximately 3 years Magnetic resonance imaging (MRI) brain volume
Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years Up to approximately 3 years Magnetic Resonance Imaging
GdE lesion volume over 3 years 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 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 Up to approximately 3 years Magnetic Resonance Imaging
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) Up to approximately 3 years Change is TSQM score over 3 years
Nine-hole Peg Test (9-HPT) Up to approximately 3 years Change from baseline in the time in seconds needed to complete test activity
Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) Up to approximately 3 years Change in WPAI score over 3 years
Fatigue Severity Scale (FSS) Up to approximately 3 years The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.
Expanded Disability Status Scale (EDSS) Up to approximately 3 years Change from baseline in EDSS score (0-10) yearly and at 3 years
Adverse Events (AEs) 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.
Trial Locations
- Locations (61)
Local Institution - 143
🇺🇸Saint 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 - 139
🇺🇸Dallas, Texas, United States
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, 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
🇺🇸Saint Louis, Missouri, 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
UC Health, LLC
🇺🇸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 - 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