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Sphingosine-1-phosphate receptor modulator

Ozanimod for Multiple Sclerosis

Phase 4

Recruiting

Led By Enrique Alvarez, MD/PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants do not have evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation

Participants must be able to undergo a brain MRI without anesthesia

Must not have

Participant has a history in the last 6 months of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure

Concomitant use of a monoamine oxidase inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

"This trial aims to see if ozanimod is safe and effective as a treatment for multiple sclerosis patients who have already been treated with anti-CD20 therapy and are currently stable."

Who is the study for?

This trial is for adults over 18 with relapsing forms of Multiple Sclerosis (MS) who've been stable on anti-CD20 therapy for at least two years, without new MS activity. They must be able to undergo an MRI and agree to contraception if applicable. Exclusions include recent heart issues, chronic infections like HIV or hepatitis, certain neurological conditions other than MS, pregnancy plans or current pregnancy/lactation, severe liver function impairment, uncontrolled diabetes or other significant medical/psychiatric illnesses.

What is being tested?

The study tests the safety and effectiveness of ozanimod as a step-down treatment in clinically stable MS patients previously treated with anti-CD20 therapies. It's a multi-center pilot study where participants will switch from their current treatment to ozanimod.

What are the potential side effects?

While not specified here, common side effects of ozanimod may include high blood pressure, liver enzyme elevations, shortness of breath, swelling in the limbs and potential increased risk of infections due to its immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had new symptoms or flare-ups of my inflammatory disease for at least two years.

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I can have a brain MRI without needing to be put to sleep.

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I am older than 18 years.

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I've been on anti-CD20 therapy for at least 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had a serious heart issue or stroke in the last 6 months.

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I am currently taking a monoamine oxidase inhibitor.

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My MS symptoms have worsened over the past year.

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My liver isn't working properly, or my liver tests are high.

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My disability from MS is severe, needing help to walk.

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I have a specific heart rhythm problem but have a working pacemaker.

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I have severe sleep apnea that hasn't been treated.

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I have type 1 diabetes, uncontrolled type 2 diabetes with HbA1c > 9%, or diabetes with serious related health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

New T2 lesions count

Serious infections

Secondary study objectives

Adverse Events

Brain parenchymal and thalamic volume loss

IgG and IgM levels

+4 more

Other study objectives

25-foot walk speed

9-hole peg test

Changes in employment

+3 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734

49%

Influenza Like Illness

12%

Headache

11%

Nasopharyngitis

Upper Respiratory Tract Infection

Orthostatic Hypotension

Pyrexia

Alanine Aminotransferase Increased

Urinary Tract Infection

Hypertension

Pharyngitis

Gamma-Glutamyltransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Interferon Beta-1a

Ozanimod 0.5 mg

Ozanimod 1 mg

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ozanimod de-escalation of anti-CD20 treatmentExperimental Treatment1 Intervention

Ozanimod will be started 6-12 months after the last anti-CD20 infusion or 30-180 days from their last ofatumumab injection. Ozanimod will be provided by the study.

Group II: Continued anti-CD20 treatmentActive Control1 Intervention

Patients will continue to receive anti-CD20. Propensity score matched to the experimental arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ozanimod

2020

Completed Phase 3

~3510

0 / 12Eligibility criteria met