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Sphingosine-1-phosphate receptor modulator
Ozanimod for Multiple Sclerosis (ENLIGHTEN Trial)
Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.
Subject has ≤ 1 approved RMS DMT at time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
ENLIGHTEN Trial Summary
This trial will test the effects of ozanimod on cognitive processing speed in 250 subjects with relapsing multiple sclerosis over the course of 36 months. 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). There is no planned protocol extension following the end of the study.
Who is the study for?
This trial is for adults aged 18-65 with Relapsing Multiple Sclerosis (RMS) diagnosed within the last 5 years. Participants should have an EDSS score of ≤3.5, can adhere to the study schedule, and have taken no more than one disease-modifying therapy (DMT). Those with other neurological disorders, significant visual or sensorimotor impairments, developmental disorders like ADHD, or major systemic diseases are excluded.Check my eligibility
What is being tested?
The study tests how ozanimod HCl 1 mg affects cognitive processing speed in RMS patients over three years. The main goal is to see if subjects show a meaningful improvement in their SDMT scores from baseline after treatment. All participants will take ozanimod orally and attend follow-up safety visits post-treatment.See study design
What are the potential side effects?
While specific side effects for ozanimod aren't listed here, similar medications may cause liver issues, respiratory problems like asthma or COPD exacerbations, infections due to immune system effects, and potential impacts on heart rate.
ENLIGHTEN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MS according to recent standards.
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I have used 1 or no approved disease-modifying treatments for RMS.
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I was diagnosed with RMS less than 5 years ago.
Select...
I am between 18 and 65 years old.
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I am between 18 and 65 years old.
ENLIGHTEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)
Secondary outcome measures
Adverse Events (AEs)
Annualized relapse rate (ARR)
Change from baseline in Symbol Digit Modalities Test (SMDT)
+17 moreSide effects data
From 2017 Phase 3 trial • 1320 Patients • NCT0204773449%
Influenza Like Illness
12%
Headache
11%
Nasopharyngitis
8%
Upper Respiratory Tract Infection
6%
Orthostatic Hypotension
6%
Pyrexia
5%
Alanine Aminotransferase Increased
4%
Urinary Tract Infection
3%
Hypertension
3%
Pharyngitis
2%
Gamma-Glutamyltransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interferon Beta-1a
Ozanimod 0.5 mg
Ozanimod 1 mg
ENLIGHTEN Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of RPC-1063Experimental Treatment1 Intervention
Patients with relapsing MS will receive RPC-1063 orally:
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Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,721 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
6,713 Patients Enrolled for Multiple Sclerosis
Michael Connor, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,280 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
17,488 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurological disorder that could explain my worsening neurological condition or affect my thinking.You have a history of conditions that affect how you learn or pay attention, like ADHD or learning disabilities.I have been diagnosed with MS according to recent standards.There are more requirements to be included in the study besides the ones listed.I have used 1 or no approved disease-modifying treatments for RMS.I do not have major health issues that would risk my participation in the study, except for mild or moderate asthma or COPD.You have been diagnosed with multiple sclerosis using specific medical guidelines.I was diagnosed with RMS less than 5 years ago.You have more than 10 lesions on your brain MRI scan taken before the study begins.I was diagnosed with RMS less than 5 years ago.I am between 18 and 65 years old.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of RPC-1063
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purpose is RPC-1063 most often prescribed?
"RPC-1063 is a medication that is used to help patients with sclerosis, and it can also be used to treat multiple sclerosis, carcinoma in situ, and active secondary progressive multiple sclerosis (spms)."
Answered by AI
What are the RPC-1063 clinical trial results thus far?
"RPC-1063 was first studied in 2015 at Local Institution - 554. So far, there have been 16 completed studies and 11 ongoing clinical trials. Many of the current trials are based in Philadelphia, Pennsylvania."
Answered by AI
Can elderly adults participate in this research?
"The age limit for participants in this trial is 65 years old. As long as participants are above 18 years old, they are eligible for this trial."
Answered by AI
Is this research project still enrolling new participants?
"That is correct, the listing on clinicaltrials.gov does show that this particular trial is currently looking for patients to enroll. The study was originally posted on 1/16/2020, with the most recent edit taking place on 10/7/2022. The trial is seeking to enroll a total of 250 participants at 61 different sites."
Answered by AI
Could you explain the current status of RPC-1063?
"RPC-1063 has gone through multiple clinical trials, so it has been deemed to be safe."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medical College
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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