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Study on the Effects of Ozanimod on Inflammation in Patients with Relapsing 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 on a condition known as Multiple Sclerosis (MS). MS is a disease that affects the brain and spinal cord, leading to symptoms like fatigue, difficulty walking, and vision problems. The study specifically looks at types of MS that have periods of worsening symptoms followed by recovery, known as Relapsing Multiple Sclerosis. The medication being tested, ozanimod, is taken as a capsule and is also known by the code name RPC1063.

The purpose of the study is to understand how ozanimod affects inflammation in the brain, particularly in areas called the meninges, which are the protective layers around the brain and spinal cord. The study will also look at how the medication impacts certain cells in the brain called glial cells, which support and protect nerve cells. Participants in the study will take ozanimod for one year, and researchers will monitor changes in specific proteins and markers in the body that are related to inflammation and nerve damage. These markers will be measured in the cerebrospinal fluid (CSF), which is the fluid surrounding the brain and spinal cord, and in the blood.

Throughout the study, participants will undergo various tests, including MRI scans, to observe any changes in the brain's structure and the presence of lesions, which are areas of damage. The study aims to provide insights into how ozanimod can help manage MS by reducing inflammation and protecting nerve cells, potentially leading to better treatment options for people living with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Participation begins after meeting specific criteria, including age between 18 and 65 years and a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 McDonald criteria.
Treatment with ozanimod must have started within 30 to 90 days before enrollment, following a specific dose escalation regimen.
Step 2
Initial Treatment Phase
The treatment involves taking Zeposia 0.92 mg hard capsules orally.
The dose escalation regimen is as follows: Days 1 to 4, 0.23 mg once daily; Days 5 to 7, 0.46 mg once daily; from Day 8 onwards, 0.92 mg once daily.
Step 3
Baseline Assessments
Before starting ozanimod, certain assessments are conducted, including the measurement of specific proteins in the cerebrospinal fluid (CSF) and serum.
An MRI scan is required, performed at least 90 days before starting ozanimod, including specific imaging sequences.
Step 4
Ongoing Treatment and Monitoring
Continue taking ozanimod 0.92 mg once daily for the duration of the study.
Regular monitoring includes measuring the concentration of specific markers in CSF and serum at the start and after one year of treatment.
Step 5
Final Assessments
After one year of treatment, final assessments are conducted to measure changes in protein concentrations, lesion numbers, and other markers of disease activity.
The study aims to understand the effect of ozanimod on inflammation and other factors in multiple sclerosis.

Who can join the trial?

10 criteria

Age between 18 and 65 years.
Diagnosed with **Relapsing-Remitting Multiple Sclerosis (RRMS)** according to the 2017 McDonald criteria. This is a type of multiple sclerosis where symptoms come and go.
Started treatment with **ozanimod** within 30 to 90 days before joining the study. Ozanimod is a medication used for treating multiple sclerosis.
Must have had at least one of the following in the past year before starting therapy:
- At least one relapse, which means a return of symptoms.
- At least one **gadolinium-enhancing lesion** or a new **T2/FLAIR lesion**. These are specific findings on an MRI scan that show changes in the brain.
- **EDSS score** between 0 and 5 at the time of starting ozanimod. The EDSS score is a way to measure disability in people with multiple sclerosis.
- At least 2 mL of **CSF** (cerebrospinal fluid) and 10 mL of blood collected before starting ozanimod and stored at -80°C. CSF is a fluid that surrounds the brain and spinal cord.
- An **MRI scan** done at least 90 days before starting ozanimod, including specific types of images like 3DT1, 3D FLAIR/T2-weighted sequences, and 3D Gradient Echo Planar Imaging Susceptibility weighted images.
- Positive for **varicella zoster virus immunoglobulin G antibody** or received a varicella zoster virus vaccination at least 28 days before starting ozanimod. This is to ensure immunity to the virus that causes chickenpox.
- Negative pregnancy test and use of highly effective contraception methods. This is to ensure safety for participants who could become pregnant.

Who cannot join the trial?

5 criteria

Patients who have a different type of multiple sclerosis than the ones being studied.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific group being studied.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Universita' Degli Studi Di Verona
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Verona, Italy

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Investigated drugs

Ozanimod is a medication being studied for its effects on inflammation in patients with Multiple Sclerosis. It is believed to help reduce inflammation in the brain and spinal cord, which may help manage symptoms and slow the progression of the disease. This study is focused on understanding how ozanimod affects specific types of inflammation and activation of certain cells in the nervous system.

Ozanimod

What is already known about the treatment

Ozanimod – Ozanimod is administered orally in the form of capsules. It is currently being studied in clinical trials for its effects on multiple sclerosis, specifically focusing on relapsing forms of the disease. The main therapeutic indication for ozanimod is to treat relapsing multiple sclerosis, including relapsing-remitting and relapsing-progressive types. At the molecular level, ozanimod works by modulating the immune system, specifically targeting certain receptors to reduce inflammation in the central nervous system. It is classified as a sphingosine-1-phosphate receptor modulator, which helps in managing the symptoms and progression of multiple sclerosis.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery, called remissions. The disease can present in different forms, such as relapsing-remitting, where symptoms come and go, or relapsing-progressive, where symptoms gradually worsen over time. During relapses, the immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, this can result in permanent damage or deterioration of the nerves themselves. The progression and severity of symptoms can vary widely among individuals.