Ozanimod for Multiple Sclerosis

(ENLIGHTEN Trial)

Recruiting at 122 trial locations

Overseen By Mary Ann Picone, Site 149

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 36 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can only have received one or fewer disease-modifying therapies for multiple sclerosis to participate.

What data supports the effectiveness of the drug Ozanimod for treating multiple sclerosis?

Research shows that Ozanimod is effective in reducing the frequency of relapses and the number of new or enlarging brain lesions in people with relapsing multiple sclerosis. It was also found to be better than interferon beta-1a in reducing disease activity, with a good safety profile. ^{1 2 3 4 5}

Is ozanimod safe for humans?

Ozanimod has been shown to be generally safe for humans, with studies indicating it is well tolerated in people with multiple sclerosis. Some potential side effects include an increased risk of infections, liver injury, and increased blood pressure, but these are not common. ^{2 3 4 5 6}

How is the drug Ozanimod unique for treating multiple sclerosis?

Ozanimod is unique because it is an oral medication that selectively targets specific receptors (S1P1 and S1P5) to prevent harmful immune cells from entering the central nervous system, reducing nerve damage and inflammation in multiple sclerosis. This targeted approach helps minimize side effects compared to other treatments. ^{2 3 4 5 6}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with MS according to recent standards.

There are more requirements to be included in the study besides the ones listed.

Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.

Exclusion 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 do not have major health issues that would risk my participation in the study, except for mild or moderate asthma or COPD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orally administered ozanimod HCl 1 mg to assess changes in cognitive processing speed over 3 years

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including a 30-day and 90-day safety follow-up visit

3 months

2 visits (in-person)

Treatment Details

Interventions

• RPC-1063

Trial Overview 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.

Participant Groups

Group I: Administration of RPC-1063 Experimental Treatment 1 Intervention

Patients with relapsing MS will receive RPC-1063 orally:

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Findings from Research

Ozanimod significantly reduces the annualized relapse rate and the number of gadolinium-enhancing lesions in adults with relapsing forms of multiple sclerosis, based on a meta-analysis of 2917 participants from three randomized controlled trials.

The 1 mg dose of ozanimod is more effective than the 0.5 mg dose in reducing relapse rates and new T2 lesions, without increasing the risk of adverse events, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ozanimod for Treatment of Relapsing-Remitting Multiple Sclerosis in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Sun, Y., Yang, Y., Wang, Z., et al.[2021]

In a comparison of ozanimod and ponesimod for treating relapsing multiple sclerosis, ozanimod showed a numerically lower annualized relapse rate and a significant reduction in brain volume loss over 2 years, indicating better efficacy in preserving brain health.

Ozanimod also had a significantly lower risk of treatment-emergent adverse events and discontinuation due to adverse events compared to ponesimod, suggesting a more favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of ozanimod and ponesimod for relapsing multiple sclerosis: A matching-adjusted indirect comparison. Swallow, E., Pham, T., Patterson-Lomba, O., et al.[2023]

Ozanimod, an oral treatment for relapsing multiple sclerosis, was found to be well tolerated in a large population of 2631 participants over an average of 32 months, with safety results consistent with earlier phase 3 trials.

The incidence rates of treatment-emergent adverse events were similar to those observed in phase 3 trials, with no new safety concerns identified, and serious complications like opportunistic infections and significant heart issues were absent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ozanimod in relapsing multiple sclerosis: Pooled safety results from the clinical development program. Selmaj, KW., Cohen, JA., Comi, G., et al.[2021]

Ozanimod, an oral sphingosine 1-phosphate receptor modulator, was approved by the US FDA in March 2020 for treating relapsing forms of multiple sclerosis, including clinically isolated syndrome and active secondary progressive disease.

The drug has also received a positive recommendation for approval in the EU and is currently being tested in phase III trials for ulcerative colitis and Crohn's disease, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ozanimod: First Approval. Lamb, YN.[2020]

Ozanimod is an effective treatment for multiple sclerosis (MS) that works by selectively modulating S1P1 and S1P5 receptors, preventing harmful immune cells from entering the central nervous system and causing damage.

While ozanimod has been shown to be well tolerated, it does carry risks such as increased infections, liver injury, and other serious side effects, highlighting the need for careful monitoring and further comparative studies with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ozanimod to Treat Relapsing Forms of Multiple Sclerosis: A Comprehensive Review of Disease, Drug Efficacy and Side Effects. Lassiter, G., Melancon, C., Rooney, T., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Ozanimod for Treatment of Relapsing-Remitting Multiple Sclerosis in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of ozanimod and ponesimod for relapsing multiple sclerosis: A matching-adjusted indirect comparison. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Ozanimod in relapsing multiple sclerosis: Pooled safety results from the clinical development program. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Ozanimod: First Approval. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Ozanimod to Treat Relapsing Forms of Multiple Sclerosis: A Comprehensive Review of Disease, Drug Efficacy and Side Effects. [2020]