Back to resultsStudy Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) (ENLIGHTEN)
Primary Purpose
Multiple Sclerosis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RPC-1063
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, RPC-1063, Ozanimod, Phase 3b
Eligibility Criteria
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).
Sites / Locations
- Local Institution - 123
- Local Institution - 136
- Local Institution - 153
- Local Institution - 162
- Local Institution - 128
- Local Institution - 164
- Local Institution - 107
- Local Institution - 102
- Local Institution - 144
- Local Institution - 109
- Local Institution - 140
- Local Institution - 158
- Local Institution - 114
- Northwest Neurology, Ltd
- Local Institution - 108
- Local Institution - 148
- Local Institution - 126
- Local Institution - 173
- Local Institution - 133
- Local Institution - 152
- Local Institution - 112
- Local Institution - 122
- Local Institution - 143
- Advanced Neurology Specialists
- Local Institution - 149
- Dent Neurologic Institute
- Local Institution - 137
- Local Institution - 160
- Local Institution - 130
- Local Institution - 121
- Local Institution - 146
- Local Institution - 131
- Local Institution - 106
- Local Institution - 170
- Raleigh Neurology Associates PA
- Local Institution - 174
- Local Institution - 171
- UC Health, LLC
- Local Institution - 157
- Local Institution - 159
- Local Institution - 169
- University of Pittsburgh Medical Center Magee Womens Hospital
- Local Institution - 125
- Local Institution - 119
- Baylor Research Institute - Dallas Clinical Trials Office
- Local Institution - 113
- Local Institution - 101
- Local Institution - 103
- Local Institution - 141
- Local Institution - 168
- Local Institution - 172
- Local Institution - 124
- Local Institution - 156
- Local Institution - 150
- Local Institution - 167
- Local Institution - 147
- Local Institution - 203
- Local Institution - 204
- Local Institution - 206
- Local Institution - 207
- Local Institution - 166
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Administration of RPC-1063
Arm Description
Patients with relapsing MS will receive RPC-1063 orally:
Outcomes
Primary Outcome Measures
Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)
Symbol Digit Modalities Test
Secondary Outcome Measures
Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)
Symbol Digit Modalities Test
Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)
Symbol Digit Modalities Test
Proportion of subjects with an increase in raw score of ≥ 3 points from baseline
Symbol Digit Modalities Test
Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline
Symbol Digit Modalities Test
Change from baseline in Symbol Digit Modalities Test (SMDT)
The SDMT is a measure of cognitive processing speed
Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes
Magnetic resonance imaging (MRI) brain volume
Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years
Magnetic Resonance Imaging
GdE lesion volume over 3 years
Magnetic Resonance Imaging
Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3
Magnetic Resonance Imaging
Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3
Magnetic Resonance Imaging
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
Change is TSQM score over 3 years
Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)
Change in WPAI score over 3 years
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
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)
The HADS was developed to identify anxiety disorders and depression among subjects in nonpsychiatric hospital clinics
Annualized relapse rate (ARR)
Change in relapse rate over 3 years
Timed 25-foot Walk (T25W)
Disability progression assessed by 20% worsening from baseline over 3 years on T25W
Nine-hole Peg Test (9-HPT)
Change from baseline in the time in seconds needed to complete test activity
Expanded Disability Status Scale (EDSS)
Change from baseline in EDSS score (0-10) yearly and at 3 years
Adverse Events (AEs)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04140305
Brief Title
Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
Acronym
ENLIGHTEN
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
January 27, 2026 (Anticipated)
Study Completion Date
April 27, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, RPC-1063, Ozanimod, Phase 3b
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Administration of RPC-1063
Arm Type
Experimental
Arm Description
Patients with relapsing MS will receive RPC-1063 orally:
Intervention Type
Drug
Intervention Name(s)
RPC-1063
Other Intervention Name(s)
Ozanimod
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)
Description
Symbol Digit Modalities Test
Time Frame
Up to approximately 3 years
Secondary Outcome Measure Information:
Title
Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)
Description
Symbol Digit Modalities Test
Time Frame
Up to approximately 3 years
Title
Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)
Description
Symbol Digit Modalities Test
Time Frame
Up to approximately 3 years
Title
Proportion of subjects with an increase in raw score of ≥ 3 points from baseline
Description
Symbol Digit Modalities Test
Time Frame
Up to approximately 3 years
Title
Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline
Description
Symbol Digit Modalities Test
Time Frame
Up to approximately 3 years
Title
Change from baseline in Symbol Digit Modalities Test (SMDT)
Description
The SDMT is a measure of cognitive processing speed
Time Frame
Up to approximately 3 years
Title
Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes
Description
Magnetic resonance imaging (MRI) brain volume
Time Frame
Up to approximately 3 years
Title
Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years
Description
Magnetic Resonance Imaging
Time Frame
Up to approximately 3 years
Title
GdE lesion volume over 3 years
Description
Magnetic Resonance Imaging
Time Frame
Up to approximately 3 years
Title
Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3
Description
Magnetic Resonance Imaging
Time Frame
Up to approximately 3 years
Title
Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3
Description
Magnetic Resonance Imaging
Time Frame
Up to approximately 3 years
Title
Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
Description
Change is TSQM score over 3 years
Time Frame
Up to approximately 3 years
Title
Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)
Description
Change in WPAI score over 3 years
Time Frame
Up to approximately 3 years
Title
Fatigue Severity Scale (FSS)
Description
The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.
Time Frame
Up to approximately 3 years
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Description
The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument
Time Frame
Up to approximately 3 years
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The HADS was developed to identify anxiety disorders and depression among subjects in nonpsychiatric hospital clinics
Time Frame
Up to approximately 3 years
Title
Annualized relapse rate (ARR)
Description
Change in relapse rate over 3 years
Time Frame
Up to approximately 3 years
Title
Timed 25-foot Walk (T25W)
Description
Disability progression assessed by 20% worsening from baseline over 3 years on T25W
Time Frame
Up to approximately 3 years
Title
Nine-hole Peg Test (9-HPT)
Description
Change from baseline in the time in seconds needed to complete test activity
Time Frame
Up to approximately 3 years
Title
Expanded Disability Status Scale (EDSS)
Description
Change from baseline in EDSS score (0-10) yearly and at 3 years
Time Frame
Up to approximately 3 years
Title
Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 123
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Local Institution - 136
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Local Institution - 153
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Local Institution - 162
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Local Institution - 128
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Local Institution - 164
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Local Institution - 107
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 102
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Local Institution - 144
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Local Institution - 109
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution - 140
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Local Institution - 158
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960-4818
Country
United States
Facility Name
Local Institution - 114
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Northwest Neurology, Ltd
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Local Institution - 108
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Local Institution - 148
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825-1603
Country
United States
Facility Name
Local Institution - 126
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Local Institution - 173
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Local Institution - 133
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Local Institution - 152
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Local Institution - 112
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Local Institution - 122
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 143
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Local Institution - 149
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Local Institution - 137
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
Facility Name
Local Institution - 160
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733-3528
Country
United States
Facility Name
Local Institution - 130
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 121
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution - 146
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Local Institution - 131
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Local Institution - 106
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Local Institution - 170
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Raleigh Neurology Associates PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Local Institution - 174
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Local Institution - 171
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
UC Health, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Local Institution - 157
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution - 159
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Local Institution - 169
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Local Institution - 125
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Local Institution - 119
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Baylor Research Institute - Dallas Clinical Trials Office
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 113
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Local Institution - 101
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78259
Country
United States
Facility Name
Local Institution - 103
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Local Institution - 141
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Local Institution - 168
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Local Institution - 172
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Local Institution - 124
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Local Institution - 156
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Local Institution - 150
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Local Institution - 167
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Local Institution - 147
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution - 203
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V4
Country
Canada
Facility Name
Local Institution - 204
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution - 206
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Local Institution - 207
City
Halifax
ZIP/Postal Code
B3R 1V9
Country
Canada
Facility Name
Local Institution - 166
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
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