Clinical trial NCT04140305: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
RPC-1063
Ozanimod
Phase 3b
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)
timeFrame: Up to approximately 3 years
measure: Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)
timeFrame: Up to approximately 3 years
measure: Proportion of subjects with an increase in raw score of ≥ 3 points from baseline
timeFrame: Up to approximately 3 years
measure: Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline
timeFrame: Up to approximately 3 years
measure: Change from baseline in Symbol Digit Modalities Test (SMDT)
timeFrame: Up to approximately 3 years
measure: Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes
timeFrame: Up to approximately 3 years
measure: Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years
timeFrame: Up to approximately 3 years
measure: GdE lesion volume over 3 years
timeFrame: Up to approximately 3 years
measure: Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3
timeFrame: Up to approximately 3 years
measure: Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3
timeFrame: Up to approximately 3 years
measure: Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
timeFrame: Up to approximately 3 years
measure: Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)
timeFrame: Up to approximately 3 years
measure: Fatigue Severity Scale (FSS)
timeFrame: Up to approximately 3 years
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: Up to approximately 3 years
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to approximately 3 years
measure: Annualized relapse rate (ARR)
timeFrame: Up to approximately 3 years
measure: Timed 25-foot Walk (T25W)
timeFrame: Up to approximately 3 years
measure: Nine-hole Peg Test (9-HPT)
timeFrame: Up to approximately 3 years
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Up to approximately 3 years
measure: Adverse Events (AEs)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 123
state: Alabama
city: Cullman
country: United States
facility: Local Institution - 136
state: Alabama
city: Mobile
country: United States
facility: Local Institution - 153
state: Alabama
city: Phoenix
country: United States
facility: Local Institution - 162
state: Arizona
city: Pasadena
country: United States
facility: Local Institution - 128
state: California
city: Sacramento
country: United States
facility: Local Institution - 164
state: California
city: Aurora
country: United States
facility: Local Institution - 107
state: Colorado
city: Colorado Springs
country: United States
facility: Local Institution - 102
state: Colorado
city: Fort Collins
country: United States
facility: Local Institution - 144
state: Colorado
city: Washington
country: United States
facility: Local Institution - 109
state: District of Columbia
city: Boca Raton
country: United States
facility: Local Institution - 140
state: Florida
city: Vero Beach
country: United States
facility: Local Institution - 158
state: Florida
city: Savannah
country: United States
facility: Local Institution - 114
state: Georgia
city: Hoffman Estates
country: United States
facility: Northwest Neurology, Ltd
state: Illinois
city: Northbrook
country: United States
facility: Local Institution - 108
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution - 148
state: Indiana
city: Ames
country: United States
facility: Local Institution - 126
state: Iowa
city: Kansas City
country: United States
facility: Local Institution - 173
state: Kansas
city: Alexandria
country: United States
facility: Local Institution - 133
state: Louisiana
city: Detroit
country: United States
facility: Local Institution - 152
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 112
state: Michigan
city: Saint Louis
country: United States
facility: Local Institution - 122
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution - 143
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Teaneck
country: United States
facility: Local Institution - 149
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Buffalo
country: United States
facility: Local Institution - 137
state: New York
city: East Setauket
country: United States
facility: Local Institution - 160
state: New York
city: New York
country: United States
facility: Local Institution - 130
state: New York
city: New York
country: United States
facility: Local Institution - 121
state: New York
city: Patchogue
country: United States
facility: Local Institution - 146
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 131
state: North Carolina
city: Greensboro
country: United States
facility: Local Institution - 106
state: North Carolina
city: Mooresville
country: United States
facility: Local Institution - 170
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates PA
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 174
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 171
state: Ohio
city: Dayton
country: United States
facility: Local Institution - 142
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 157
state: Oklahoma
city: Philadelphia
country: United States
facility: Local Institution - 159
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 169
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Magee Womens Hospital
state: Pennsylvania
city: Franklin
country: United States
facility: Local Institution - 125
state: Tennessee
city: Knoxville
country: United States
facility: Local Institution - 119
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 139
state: Texas
city: Round Rock
country: United States
facility: Local Institution - 113
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 101
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 103
state: Virginia
city: Kirkland
country: United States
facility: Local Institution - 141
state: Washington
city: Seattle
country: United States
facility: Local Institution - 168
state: Washington
city: Spokane
country: United States
facility: Local Institution - 172
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 124
state: Washington
city: Huntington
country: United States
facility: Local Institution - 156
state: West Virginia
city: Morgantown
country: United States
facility: Local Institution - 150
state: West Virginia
city: Madison
country: United States
facility: Local Institution - 167
state: Wisconsin
city: Milwaukee
country: United States
facility: Local Institution - 147
state: Wisconsin
city: London
country: Canada
facility: Local Institution - 203
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution - 204
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 206
state: Quebec
city: Halifax
country: Canada
facility: Local Institution - 207
city: Guaynabo
country: Puerto Rico
facility: Local Institution - 166
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: