Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) (ENLIGHTEN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04140305 |
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Recruitment Status :
Active, not recruiting
First Posted : October 25, 2019
Last Update Posted : March 10, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis | Drug: RPC-1063 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 250 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | January 16, 2020 |
| Estimated Primary Completion Date : | January 27, 2026 |
| Estimated Study Completion Date : | April 27, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Administration of RPC-1063
Patients with relapsing MS will receive RPC-1063 orally:
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Drug: RPC-1063
Oral capsule
Other Name: Ozanimod |
- Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved) [ Time Frame: Up to approximately 3 years ]Symbol Digit Modalities Test
- Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened) [ Time Frame: 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) [ Time Frame: Up to approximately 3 years ]Symbol Digit Modalities Test
- Proportion of subjects with an increase in raw score of ≥ 3 points from baseline [ Time Frame: Up to approximately 3 years ]Symbol Digit Modalities Test
- Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline [ Time Frame: Up to approximately 3 years ]Symbol Digit Modalities Test
- Change from baseline in Symbol Digit Modalities Test (SMDT) [ Time Frame: Up to approximately 3 years ]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 [ Time Frame: Up to approximately 3 years ]Magnetic resonance imaging (MRI) brain volume
- Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years [ Time Frame: Up to approximately 3 years ]Magnetic Resonance Imaging
- GdE lesion volume over 3 years [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to approximately 3 years ]Magnetic Resonance Imaging
- Treatment Satisfaction Questionnaire for Medication (TSQM v1.4) [ Time Frame: Up to approximately 3 years ]Change is TSQM score over 3 years
- Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) [ Time Frame: Up to approximately 3 years ]Change in WPAI score over 3 years
- Fatigue Severity Scale (FSS) [ Time Frame: Up to approximately 3 years ]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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to approximately 3 years ]Change in relapse rate over 3 years
- Timed 25-foot Walk (T25W) [ Time Frame: Up to approximately 3 years ]Disability progression assessed by 20% worsening from baseline over 3 years on T25W
- Nine-hole Peg Test (9-HPT) [ Time Frame: Up to approximately 3 years ]Change from baseline in the time in seconds needed to complete test activity
- Expanded Disability Status Scale (EDSS) [ Time Frame: Up to approximately 3 years ]Change from baseline in EDSS score (0-10) yearly and at 3 years
- Adverse Events (AEs) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140305
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT04140305 |
| Other Study ID Numbers: |
RPC-1063-MS-001 U1111-1240-5667 ( Other Identifier: WHO ) |
| First Posted: | October 25, 2019 Key Record Dates |
| Last Update Posted: | March 10, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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/ |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Sclerosis RPC-1063 Ozanimod Phase 3b |
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Ozanimod Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |