Ozanimod for Multiple Sclerosis

(ENLIGHTEN Trial)

Recruiting at 122 trial locations

Overseen By Faria Amjad, Site 109

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Celgene

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

Treatment Details

Interventions

• RPC-1063 (Sphingosine-1-phosphate receptor modulator)

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