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Study on the Effectiveness and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Children with 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 treatment of Multiple Sclerosis in children and teenagers. The study will compare the effectiveness and safety of two medications, Ofatumumab and Siponimod, against another medication called Fingolimod. Ofatumumab is given as an injection under the skin, while Siponimod and Fingolimod are taken as tablets by mouth. The purpose of the study is to see if Ofatumumab and Siponimod are not worse than Fingolimod in managing the disease.

Participants in the study will be randomly assigned to one of three groups, each receiving one of the medications or a placebo. The study will last for up to two years, during which time the participants will receive regular check-ups and monitoring. This will include assessments like MRI scans, which are imaging tests that help doctors see inside the body, and blood tests to measure certain substances in the blood. The study will also track any side effects or health changes that occur during the treatment period.

The main goal is to observe the annualized relapse rate, which means how often the symptoms of Multiple Sclerosis return or worsen over a year. Other aspects being studied include the number of new or growing lesions in the brain, which are areas of damage caused by the disease, and the presence of antibodies against Ofatumumab. The study will also look at the concentration of a protein called neurofilament light chain in the blood, which can indicate nerve damage. Participants' overall health, including heart and lung function, will be monitored throughout the study.

The research process

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

  1. Step 1

    Randomization and initial assessment

    Upon joining the study, the patient is randomly assigned to one of three groups. Each group receives a different treatment: ofatumumab, siponimod, or fingolimod.

    An initial assessment is conducted to evaluate the patient's health status and confirm eligibility based on criteria such as age, diagnosis of multiple sclerosis, and previous medical history.

  2. Step 2

    Treatment phase

    The patient begins the treatment phase, which lasts for up to two years.

    If assigned to the ofatumumab group, the patient receives the medication via subcutaneous injection. The dosage and frequency are determined by the study protocol.

    If assigned to the siponimod group, the patient takes the medication orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.

    If assigned to the fingolimod group, the patient takes the medication orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the treatment phase, the patient's health is regularly monitored through various assessments.

    These assessments include measuring the annualized relapse rate, conducting MRI scans to check for new or enlarging lesions, and evaluating neurofilament light chain concentration in the blood.

    Additional tests may include checking for anti-ofatumumab antibodies, monitoring for any adverse events, and conducting routine health checks such as ECGs, laboratory tests, and pulmonary function tests.

  4. Step 4

    Open-label extension

    After completing the initial two-year treatment phase, the patient may enter an open-label extension phase.

    During this phase, the patient continues to receive treatment, and further monitoring and assessments are conducted to gather additional data on the long-term effects and safety of the medications.

Who can join the trial?

5 criteria

  • Signed informed consent or assent must be obtained before participating in the study. This means that the patient and their guardian agree to join the study after understanding what it involves.
  • The patient must be between 10 and less than 18 years old at the time of joining the study. This means they have not yet had their 18th birthday.
  • The patient must have a diagnosis of **Multiple Sclerosis (MS)**, which is a condition affecting the brain and spinal cord, as defined by the guidelines for pediatric MS.
  • The patient must have an **Expanded Disability Status Scale (EDSS)** score between 0 and 5.5 at the time of screening. The EDSS is a method used to measure the level of disability in people with MS.
  • The patient must have experienced at least one MS relapse or attack in the past year, or two relapses in the past two years before screening. Alternatively, there must be evidence of one or more new **T2 lesions** on an **MRI** scan within 12 months before joining the study, or one or more **Gd-enhancing T1 lesions** on an MRI scan within the same period. An MRI is a type of scan that creates detailed images of the inside of the body, and lesions are areas of damage or change in the brain or spinal cord.
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Investigated drugs

  • Ofatumumab

    is a medication used in this trial to treat pediatric patients with multiple sclerosis. It works by targeting specific cells in the immune system that are involved in the disease process, helping to reduce inflammation and prevent relapses.

  • Siponimod

    is another medication being tested in the trial for its effectiveness in treating multiple sclerosis in children. It helps to modulate the immune system, potentially reducing the frequency of relapses and slowing the progression of the disease.

  • Fingolimod

    is a medication already used in the treatment of multiple sclerosis. In this trial, it serves as a comparison to evaluate the effectiveness and safety of ofatumumab and siponimod. Fingolimod works by trapping certain immune cells in the lymph nodes, preventing them from reaching the brain and spinal cord, which helps to reduce the number of relapses.

What is already known about the treatment

  • Ofatumumab

    Ofatumumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating multiple sclerosis in pediatric patients. The main therapeutic indication is to reduce the frequency of relapses in multiple sclerosis. At the molecular level, ofatumumab works by targeting and depleting specific immune cells that are involved in the disease process. It is classified as a monoclonal antibody.

  • Siponimod

    Siponimod is taken orally in the form of tablets. It is under investigation in clinical trials for its potential to treat multiple sclerosis in children. The primary therapeutic use is to manage and reduce the progression of multiple sclerosis. Siponimod functions by modulating the immune system, specifically affecting certain receptors to prevent immune cells from causing damage. It belongs to the class of sphingosine-1-phosphate receptor modulators.

  • Fingolimod

    Fingolimod is administered orally as a capsule. It is an established treatment for multiple sclerosis and is being compared to other medications in clinical trials for pediatric use. Its main therapeutic role is to decrease the frequency of relapses and delay disability progression in multiple sclerosis. Fingolimod works by trapping immune cells in the lymph nodes, preventing them from reaching the central nervous system and causing damage. It is classified as a sphingosine-1-phosphate receptor modulator.

Investigated diseases

Multiple Sclerosis in pediatric patients – Multiple Sclerosis (MS) is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. In pediatric patients, it can cause a range of symptoms such as fatigue, difficulty walking, and problems with coordination and balance. The disease is characterized by episodes of new or worsening symptoms, known as relapses, followed by periods of partial or complete recovery. Over time, MS can lead to a gradual decline in neurological function. The progression and severity of symptoms can vary widely among individuals. Pediatric MS is less common than adult-onset MS, but it can significantly impact a child's development and quality of life.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-511686-11-00Protocol codeCBAF312D2301Estimated enrolment141 patientsSponsorNovartis Pharma AG

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