Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

Multiple Sclerosis Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04140305
• Other study ID #: RPC-1063-MS-001
• Secondary ID: U1111-1240-5667
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 16, 2020
• Est. completion date: April 27, 2026

Study information

• Verified date: November 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: April 27, 2026
• Est. primary completion date: January 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• RPC-1063
Oral capsule

Locations

Country	Name	City	State
Canada	Local Institution - 207	Halifax
Canada	Local Institution - 203	London	Ontario
Canada	Local Institution - 206	Montreal	Quebec
Canada	Local Institution - 204	Ottawa	Ontario
Puerto Rico	Local Institution - 166	Guaynabo
United States	Local Institution - 133	Alexandria	Louisiana
United States	Local Institution - 126	Ames	Iowa
United States	Dent Neurologic Institute	Amherst	New York
United States	Local Institution - 107	Aurora	Colorado
United States	Local Institution - 123	Birmingham	Alabama
United States	Local Institution - 140	Boca Raton	Florida
United States	Local Institution - 137	Buffalo	New York
United States	Local Institution - 131	Chapel Hill	North Carolina
United States	Local Institution - 174	Cincinnati	Ohio
United States	Local Institution - 171	Cleveland	Ohio
United States	Local Institution - 102	Colorado Springs	Colorado
United States	Local Institution - 136	Cullman	Alabama
United States	Baylor Research Institute - Dallas Clinical Trials Office	Dallas	Texas
United States	UC Health, LLC	Dayton	Ohio
United States	Local Institution - 112	Detroit	Michigan
United States	Local Institution - 152	Detroit	Michigan
United States	Local Institution - 160	East Setauket	New York
United States	Local Institution - 144	Fort Collins	Colorado
United States	Local Institution - 148	Fort Wayne	Indiana
United States	Local Institution - 125	Franklin	Tennessee
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	Local Institution - 106	Greensboro	North Carolina
United States	Northwest Neurology, Ltd	Hoffman Estates	Illinois
United States	Local Institution - 156	Huntington	West Virginia
United States	Local Institution - 173	Kansas City	Kansas
United States	Local Institution - 141	Kirkland	Washington
United States	Local Institution - 119	Knoxville	Tennessee
United States	Local Institution - 167	Madison	Wisconsin
United States	Local Institution - 147	Milwaukee	Wisconsin
United States	Local Institution - 153	Mobile	Alabama
United States	Local Institution - 170	Mooresville	North Carolina
United States	Local Institution - 150	Morgantown	West Virginia
United States	Local Institution - 121	New York	New York
United States	Local Institution - 130	New York	New York
United States	Local Institution - 103	Norfolk	Virginia
United States	Local Institution - 108	Northbrook	Illinois
United States	Local Institution - 157	Oklahoma City	Oklahoma
United States	Local Institution - 128	Pasadena	California
United States	Local Institution - 146	Patchogue	New York
United States	Local Institution - 159	Philadelphia	Pennsylvania
United States	Local Institution - 169	Philadelphia	Pennsylvania
United States	Local Institution - 162	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Raleigh Neurology Associates PA	Raleigh	North Carolina
United States	Local Institution - 113	Round Rock	Texas
United States	Local Institution - 164	Sacramento	California
United States	Local Institution - 122	Saint Louis	Missouri
United States	Local Institution - 143	Saint Louis	Missouri
United States	Local Institution - 101	San Antonio	Texas
United States	Local Institution - 114	Savannah	Georgia
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 - 149	Teaneck	New Jersey
United States	Local Institution - 158	Vero Beach	Florida
United States	Local Institution - 109	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with an increase in raw score of = 4 points or 10% from baseline (improved)	Symbol Digit Modalities Test	Up to approximately 3 years
Secondary	Proportion of subjects with a decrease in raw score of = 4 points or 10% from baseline (worsened)	Symbol Digit Modalities Test	Up to approximately 3 years
Secondary	Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)	Symbol Digit Modalities Test	Up to approximately 3 years
Secondary	Proportion of subjects with an increase in raw score of = 3 points from baseline	Symbol Digit Modalities Test	Up to approximately 3 years
Secondary	Proportion of subjects with a decrease in raw score of = 3 points from baseline	Symbol Digit Modalities Test	Up to approximately 3 years
Secondary	Change from baseline in Symbol Digit Modalities Test (SMDT)	The SDMT is a measure of cognitive processing speed	Up to approximately 3 years
Secondary	Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes	Magnetic resonance imaging (MRI) brain volume	Up to approximately 3 years
Secondary	Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years	Magnetic Resonance Imaging	Up to approximately 3 years
Secondary	GdE lesion volume over 3 years	Magnetic Resonance Imaging	Up to approximately 3 years
Secondary	Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3	Magnetic Resonance Imaging	Up to approximately 3 years
Secondary	Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3	Magnetic Resonance Imaging	Up to approximately 3 years
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)	Change is TSQM score over 3 years	Up to approximately 3 years
Secondary	Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)	Change in WPAI score over 3 years	Up to approximately 3 years
Secondary	Fatigue Severity Scale (FSS)	The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.	Up to approximately 3 years
Secondary	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	Up to approximately 3 years
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS was developed to identify anxiety disorders and depression among subjects in nonpsychiatric hospital clinics	Up to approximately 3 years
Secondary	Annualized relapse rate (ARR)	Change in relapse rate over 3 years	Up to approximately 3 years
Secondary	Timed 25-foot Walk (T25W)	Disability progression assessed by 20% worsening from baseline over 3 years on T25W	Up to approximately 3 years
Secondary	Nine-hole Peg Test (9-HPT)	Change from baseline in the time in seconds needed to complete test activity	Up to approximately 3 years
Secondary	Expanded Disability Status Scale (EDSS)	Change from baseline in EDSS score (0-10) yearly and at 3 years	Up to approximately 3 years
Secondary	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.	Up to approximately 3 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting