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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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am between 18 and 65 years old.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurological disorder that could explain my worsening neurological condition or affect my thinking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)
Secondary study objectives
Adverse Events (AEs)
Annualized relapse rate (ARR)
Change from baseline in Symbol Digit Modalities Test (SMDT)
+17 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734
49%
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

Awards & Highlights

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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of RPC-1063Experimental Treatment1 Intervention
Patients with relapsing MS will receive RPC-1063 orally:

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
129,933 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
6,907 Patients Enrolled for Multiple Sclerosis
Michael Connor, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,579 Previous Clinical Trials
3,387,370 Total Patients Enrolled
12 Trials studying Multiple Sclerosis
16,916 Patients Enrolled for Multiple Sclerosis

Media Library

RPC-1063 (Sphingosine-1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04140305 — Phase 3
Multiple Sclerosis Research Study Groups: Administration of RPC-1063
Multiple Sclerosis Clinical Trial 2023: RPC-1063 Highlights & Side Effects. Trial Name: NCT04140305 — Phase 3
RPC-1063 (Sphingosine-1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04140305 — Phase 3
~45 spots leftby Jan 2026
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