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Study on the Effects of Siponimod on Imaging and Immune Markers in Patients with Progressive 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 the medication siponimod on individuals with a type of multiple sclerosis known as progressive multiple sclerosis. Multiple sclerosis is a disease where the immune system attacks the protective covering of nerves, which can lead to various neurological problems. The trial will use different doses of Mayzent tablets, which contain the active ingredient siponimod, also known by its code name BAF312. The purpose of the study is to evaluate how siponimod affects certain brain lesions, which are areas of damage, as seen on an MRI scan, in patients with secondary progressive multiple sclerosis.

Participants in the study will take the medication orally in the form of film-coated tablets. The study will compare the changes in the brain lesions before and after treatment with siponimod. The trial will also look at other factors, such as changes in specific markers in the blood and cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord, to understand the medication's impact on the immune system and nerve damage. Additionally, the study will monitor any side effects that may occur during the treatment period.

The trial will last for up to two years, during which participants will have regular follow-up visits to assess the effects of the treatment. The study aims to provide valuable insights into how siponimod can help manage progressive multiple sclerosis and improve the understanding of its impact on the disease's progression. This research could potentially lead to better treatment options for individuals living with this challenging 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.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, neurological evaluations, and MRI scans performed within the last two years.

    Eligibility criteria include being between 18-65 years old, having an active progressive multiple sclerosis course, and an EDSS score between 3.0 and 6.0.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish a starting point for the study. This includes MRI scans to assess paramagnetic rim lesions and blood tests to measure specific markers in the cerebrospinal fluid and serum.

  3. Step 3

    Medication administration

    The medication used in the study is siponimod, administered in the form of film-coated tablets. The specific dosage and frequency are determined by the study protocol and may vary based on individual patient needs.

    The medication is taken orally, and the treatment phase lasts for up to two years.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled throughout the study to monitor progress and assess any changes in the condition. These visits include MRI scans and blood tests to evaluate the effect of siponimod on the disease.

    The study aims to observe changes in paramagnetic rim lesions and other markers over time, comparing them to baseline measurements.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of the disease progression and the effects of the medication.

    The primary endpoint is the change in susceptibility of rim lesions, while secondary endpoints include changes in specific markers and cognitive functioning.

Who can join the trial?

7 criteria

  • Must be between 18 and 65 years old.
  • Have an active progressive multiple sclerosis (MS) course after an initial relapse. This means the disease is getting worse, with at least 1 point increase in the Expanded Disability Status Scale (EDSS), a tool used to measure disability in MS. There should be a history of relapse or new signs of disease activity on an MRI scan in the last 2 years.
  • Have a 3T MRI scan done in the last 2 years. This scan should include specific types of images: 3D T1 weighted Fast Field Echo (FFE), 3D Fluid Attenuated Inversion Recovery (FLAIR), and 3D Echo Planar Imaging Susceptibility weighted images.
  • Have detailed medical history records, including at least two neurological evaluations in the past two years, or one in the past year.
  • Have an EDSS score between 3.0 and 6.0, indicating a certain level of disability.
  • Have been in the progressive phase of the disease for less than 5 years.
  • Female participants must not be pregnant or breastfeeding at the start of the study or during the study period.

Who cannot join the trial?

1 criterion

  • Patients with an active progressive multiple sclerosis course after an initial relapse clinical course cannot participate. This means if your multiple sclerosis is currently getting worse after having a period of getting better, you are not eligible.
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Investigated drugs

Siponimod is a medication being studied for its effects on progressive multiple sclerosis (MS). It is being evaluated to see how it impacts specific brain lesions that are visible on MRI scans in patients with secondary progressive MS. The goal is to understand if siponimod can help reduce or alter these lesions, which are important markers of the disease's progression.

What is already known about the treatment

Siponimod – Siponimod is administered orally in tablet form and is currently being studied for its effects on progressive multiple sclerosis, particularly in patients with an active progressive course following an initial relapse. It is approved for use in certain types of multiple sclerosis and is being evaluated for its impact on specific MRI markers in secondary progressive MS. The medication works by modulating the immune system, specifically targeting certain receptors on white blood cells to reduce inflammation and prevent further nerve damage. Siponimod is classified as a sphingosine-1-phosphate receptor modulator, which helps in managing the progression of multiple sclerosis by influencing immune cell activity.

Investigated diseases

Secondary Progressive Multiple Sclerosis – This is a form of multiple sclerosis (MS) that follows an initial relapsing-remitting course. Over time, the disease transitions into a phase where there is a progressive worsening of neurological function. Unlike the initial phase, relapses become less frequent or stop altogether, but disability continues to increase. The progression can vary greatly among individuals, with some experiencing a steady decline and others having periods of stability. Symptoms may include increased difficulty with mobility, cognitive changes, and fatigue. The exact cause of this progression is not fully understood, but it involves ongoing inflammation and damage to the nervous system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518374-13-00Protocol codeSIPO20Estimated enrolment60 patientsSponsorAzienda Ospedaliera Universitaria Integrata Verona

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