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Multiple SclerosisPhase 3ENLIGHTENNCT04140305

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

A Phase 3 study testing RPC-1063 in people with Multiple Sclerosis, run by Celgene at 61 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
RPC-1063
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
61 sitesin 3 countries
Study dates
16 Jan 2020to 15 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

61 sites in 3 countries.

61 sites in 3 countries

United States56 sites

  • Local Institution - 133

    Alexandria, Louisiana, 71301

  • Local Institution - 126

    Ames, Iowa, 50010

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Local Institution - 107

    Aurora, Colorado, 80045

  • Local Institution - 123

    Birmingham, Alabama, 35209

  • Local Institution - 140

    Boca Raton, Florida, 33428

  • Local Institution - 137

    Buffalo, New York, 14202

  • Local Institution - 131

    Chapel Hill, North Carolina, 27514

  • Local Institution - 174

    Cincinnati, Ohio, 45219

  • Local Institution - 171

    Cleveland, Ohio, 44106

  • Local Institution - 102

    Colorado Springs, Colorado, 80907

  • Local Institution - 136

    Cullman, Alabama, 35058

  • Local Institution - 139

    Dallas, Texas, 75246

  • Local Institution - 142

    Dayton, Ohio, 45417

  • Local Institution - 152

    Detroit, Michigan, 48201

  • Local Institution - 112

    Detroit, Michigan, 48202

  • Local Institution - 160

    East Setauket, New York, 11733-3528

  • Local Institution - 144

    Fort Collins, Colorado, 80528

  • Local Institution - 148

    Fort Wayne, Indiana, 46825-1603

  • Local Institution - 125

    Franklin, Tennessee, 37064

  • Advanced Neurology Specialists

    Great Falls, Montana, 59405

  • Local Institution - 106

    Greensboro, North Carolina, 27405

  • Northwest Neurology, Ltd

    Hoffman Estates, Illinois, 60169

  • Local Institution - 156

    Huntington, West Virginia, 25701

  • Local Institution - 173

    Kansas City, Kansas, 66160

  • Local Institution - 141

    Kirkland, Washington, 98034

  • Local Institution - 119

    Knoxville, Tennessee, 37922

  • Local Institution - 167

    Madison, Wisconsin, 53792

  • Local Institution - 147

    Milwaukee, Wisconsin, 53226

  • Local Institution - 153

    Mobile, Alabama, 36617

  • Local Institution - 170

    Mooresville, North Carolina, 28117

  • Local Institution - 150

    Morgantown, West Virginia, 26506

  • Local Institution - 130

    New York, New York, 10016

  • Local Institution - 121

    New York, New York, 10021

  • Local Institution - 103

    Norfolk, Virginia, 23502

  • Local Institution - 108

    Northbrook, Illinois, 60062

  • Local Institution - 157

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 128

    Pasadena, California, 91105

  • Local Institution - 146

    Patchogue, New York, 11772

  • Local Institution - 159

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 169

    Philadelphia, Pennsylvania, 19140

  • Local Institution - 162

    Phoenix, Arizona, 85018

  • University of Pittsburgh Medical Center Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Raleigh Neurology Associates PA

    Raleigh, North Carolina, 27607

  • Local Institution - 113

    Round Rock, Texas, 78681

  • Local Institution - 164

    Sacramento, California, 95817

  • Local Institution - 101

    San Antonio, Texas, 78259

  • Local Institution - 114

    Savannah, Georgia, 31406

  • Local Institution - 168

    Seattle, Washington, 98101

  • Local Institution - 172

    Spokane, Washington, 99202

  • Local Institution - 122

    St Louis, Missouri, 63110

  • Local Institution - 143

    St Louis, Missouri, 63131

  • Local Institution - 124

    Tacoma, Washington, 98405

  • Local Institution - 149

    Teaneck, New Jersey, 07666

  • Local Institution - 158

    Vero Beach, Florida, 32960-4818

  • Local Institution - 109

    Washington D.C., District of Columbia, 20007

Other trials in United States

Canada4 sites

  • Local Institution - 207

    Halifax, B3R 1V9

  • Local Institution - 203

    London, Ontario, N6G 2V4

  • Local Institution - 206

    Montreal, Quebec, H2X 0A9

  • Local Institution - 204

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Puerto Rico1 site

  • Local Institution - 166

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

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)

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.

Being tested
RPC-1063
Keywords
Multiple Sclerosis, RPC-1063, Ozanimod, Phase 3b
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RPC-1063Drug

    Also called Ozanimod

    Oral capsule

Study groups in NCT04140305
Study groupRoleWhat they receive
Administration of RPC-1063ExperimentalPatients with relapsing MS will receive RPC-1063 orally:
Receives: Drug: RPC-1063

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)

    Symbol Digit Modalities Test

    Measured: Up to approximately 3 years

Secondary outcomes (20)

  1. Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)

    Symbol Digit Modalities Test

    Measured: Up to approximately 3 years

  2. Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)

    Symbol Digit Modalities Test

    Measured: Up to approximately 3 years

  3. Proportion of subjects with an increase in raw score of ≥ 3 points from baseline

    Symbol Digit Modalities Test

    Measured: Up to approximately 3 years

  4. Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline

    Symbol Digit Modalities Test

    Measured: Up to approximately 3 years

  5. Change from baseline in Symbol Digit Modalities Test (SMDT)

    The SDMT is a measure of cognitive processing speed

    Measured: Up to approximately 3 years

  6. Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes

    Magnetic resonance imaging (MRI) brain volume

    Measured: Up to approximately 3 years

  7. Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years

    Magnetic Resonance Imaging

    Measured: Up to approximately 3 years

  8. GdE lesion volume over 3 years

    Magnetic Resonance Imaging

    Measured: Up to approximately 3 years

  9. Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3

    Magnetic Resonance Imaging

    Measured: Up to approximately 3 years

  10. Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3

    Magnetic Resonance Imaging

    Measured: Up to approximately 3 years

  11. Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)

    Change is TSQM score over 3 years

    Measured: Up to approximately 3 years

  12. Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)

    Change in WPAI score over 3 years

    Measured: Up to approximately 3 years

  13. Fatigue Severity Scale (FSS)

    The Fatigue Severity Scale (FSS) questionnaire contains nine statements that attempt to explore severity of fatigue symptoms.

    Measured: Up to approximately 3 years

  14. 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

    Measured: Up to approximately 3 years

  15. Hospital Anxiety and Depression Scale (HADS)

    The HADS was developed to identify anxiety disorders and depression among subjects in nonpsychiatric hospital clinics

    Measured: Up to approximately 3 years

  16. Annualized relapse rate (ARR)

    Change in relapse rate over 3 years

    Measured: Up to approximately 3 years

  17. Timed 25-foot Walk (T25W)

    Disability progression assessed by 20% worsening from baseline over 3 years on T25W

    Measured: Up to approximately 3 years

  18. Nine-hole Peg Test (9-HPT)

    Change from baseline in the time in seconds needed to complete test activity

    Measured: Up to approximately 3 years

  19. Expanded Disability Status Scale (EDSS)

    Change from baseline in EDSS score (0-10) yearly and at 3 years

    Measured: Up to approximately 3 years

  20. 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.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2019
  2. Study start16 Jan 2020
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Why it stopped: Business objective has changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140305
Sponsor's protocol ID
RPC-1063-MS-001
Other IDs
U1111-1240-5667
Acronym
ENLIGHTEN
Status last verified
Jun 2025
First submitted
24 Oct 2019
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RPC-1063 in people with Multiple Sclerosis, run by Celgene at 61 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objective has changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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ENLIGHTEN Clinical Trial NCT04140305 | AzTrials