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Study on the Effects of Ozanimod in Patients with Relapsing-Remitting Multiple Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called ozanimod in patients with relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a disease where the immune system mistakenly attacks the protective covering of nerves, which can lead to symptoms like fatigue, difficulty walking, and problems with vision. The purpose of this study is to evaluate how ozanimod can help limit the progression of brain damage over a period of two years in people with this condition.

Participants in the study will receive ozanimod, which is taken orally, meaning it is swallowed in pill form. The study will observe changes in the brain, such as overall brain shrinkage and specific areas like the gray matter, white matter, thalamus, and cortex. These observations will help researchers understand how the medication affects the brain and whether it can slow down the damage caused by the disease.

Throughout the study, researchers will also look at how ozanimod impacts other aspects of the participants' lives, including their cognitive abilities, levels of fatigue, mood, and overall quality of life. This comprehensive approach aims to provide a better understanding of how the medication can improve the daily lives of those living with relapsing-remitting multiple sclerosis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of relapsing-remitting multiple sclerosis (RRMS), and completion of planned vaccinations.
Participants must provide informed consent and agree to use effective contraception if applicable.
Step 2
Treatment initiation
Participants begin treatment with ozanimod, a medication taken orally. The dosage and frequency are determined according to guidelines from the European Medicines Agency and Italian Medicine Agency.
The treatment aims to limit the progression of brain neurodegenerative phenomena over a period of 2 years.
Step 3
Ongoing monitoring
Throughout the 2-year study period, regular monitoring is conducted to assess changes in brain volume, including global brain atrophy, regional gray matter volume, white matter volume, thalamic volume, and cortical volume.
These assessments help evaluate the effects of ozanimod on myelin dynamics and neurodegeneration.
Step 4
Final evaluation
At the end of the 2-year period, a final evaluation is performed to measure the overall impact of the treatment on disease activity, cognition, fatigue, depression, and quality of life.
The study concludes with a comprehensive analysis of the collected data to determine the effectiveness of ozanimod in managing RRMS.

Who can join the trial?

7 criteria

Must be between 18 and 55 years old.
Must have a diagnosis of **RRMS** (Relapsing-Remitting Multiple Sclerosis) according to specific medical guidelines from 2017.
Must be starting treatment with **ozanimod**, a medication approved by European and Italian health agencies.
Must have an **EDSS score** of 5.0 or less. The **EDSS score** is a way to measure disability in people with multiple sclerosis.
Must have completed all planned vaccinations before joining the study.
Must provide a signed informed consent form to participate in the trial. This means you agree to join the study after understanding all the details.
If you are a woman who can have children or a man whose partner can have children, you must agree to use effective birth control during the study and for 3 months after it ends.

Who cannot join the trial?

3 criteria

Patients who do not have multiple sclerosis in the relapse and remission form cannot participate. Multiple sclerosis is a condition where the immune system attacks the protective covering of nerves.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

Ozanimod is a medication being studied for its effects on patients with relapsing-remitting multiple sclerosis (RRMS). It is being evaluated for its ability to limit the progression of brain neurodegenerative phenomena over a period of two years. The study aims to understand how this medication can impact disease activity, cognition, fatigue, depression, and overall quality of life in patients.

Ozanimod Hydrochloride

What is already known about the treatment

Ozanimod – This medication is administered orally in the form of capsules. It is currently being studied in clinical trials for its effects on relapsing-remitting multiple sclerosis (RRMS). The main therapeutic indication is to limit the progression of neurodegenerative processes in the brain associated with this condition. At the molecular level, ozanimod works by modulating the immune system, specifically targeting certain receptors to reduce inflammation and prevent immune cells from attacking the nervous system. It is classified as a sphingosine-1-phosphate receptor modulator.

Investigated diseases

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system mistakenly attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. The disease can manifest in various forms, with relapsing-remitting multiple sclerosis (RRMS) being the most common. In RRMS, patients experience episodes of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions). Over time, the disease may progress, leading to increased disability. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and problems with coordination and balance.