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Study on the Safety and Effectiveness of Ocrelizumab vs. Fingolimod for Children and Adolescents 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 a condition known as Relapsing-Remitting Multiple Sclerosis, which is a type of multiple sclerosis characterized by periods of new or increasing symptoms followed by periods of partial or complete recovery. The study is comparing two treatments: Ocrelizumab and Fingolimod. Ocrelizumab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein, while Fingolimod is taken orally in the form of hard capsules. The trial also includes a placebo, which is a substance with no active medication, to help understand the effects of the treatments better.

The purpose of the study is to evaluate the safety and effectiveness of Ocrelizumab compared to Fingolimod in children and adolescents with Relapsing-Remitting Multiple Sclerosis. Participants in the study will receive either Ocrelizumab or Fingolimod, and their health will be monitored over a period of time to observe any changes in their condition. The study aims to determine if Ocrelizumab is not inferior to Fingolimod in terms of reducing the annualized relapse rate, which is a measure of how often relapses occur over a year.

Throughout the study, participants will undergo various assessments, including MRI scans, to check for changes in the brain and to monitor the number of new or enlarging lesions. The study will also track any side effects or adverse events that may occur. This research is important for understanding how these treatments can help manage Relapsing-Remitting Multiple Sclerosis in younger patients and to ensure their safety and effectiveness.

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

    Upon joining the study, participants are randomly assigned to receive either ocrelizumab or fingolimod. This process ensures that each participant has an equal chance of receiving either treatment.

  2. Step 2

    Treatment administration

    Participants receiving fingolimod will take Gilenya 0.5 mg hard capsules orally. The dosage and frequency are determined by the study protocol.

    Participants receiving ocrelizumab will receive Ocrevus 300 mg as an intravenous infusion. The frequency and duration of administration are specified in the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes brain MRI scans to detect new or enlarging lesions, and assessments of any adverse events.

    Blood tests are conducted to measure levels of CD19 B-cells and to check for the presence of anti-drug antibodies against ocrelizumab.

  4. Step 4

    End of treatment

    The study is estimated to conclude by September 17, 2029. At the end of the treatment period, participants will undergo final assessments to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

6 criteria

  • Age between 10 to less than 18 years at the time of joining the study, with a body weight of at least 25 kilograms.
  • Must have had at least one episode of symptoms returning in the year before joining the study, or two episodes in the two years before joining, or must show signs of at least one area of brain inflammation on an MRI scan within 6 months before joining the study.
  • Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where symptoms come and go, confirmed by a special committee before joining the study.
  • Must have received all recommended childhood vaccinations according to local or national guidelines to protect against infectious diseases.
  • Must have a score between 0 and 5.5 on the Expanded Disability Status Scale (EDSS), which is a way to measure disability in people with multiple sclerosis.
  • Female participants who can have children must agree to either not have heterosexual intercourse or use birth control during the treatment period and for at least 24 weeks after the last dose of the study medication, and for 2 months after the last dose of another study medication.

Who cannot join the trial?

10 criteria

  • Patients with any other type of multiple sclerosis other than Relapsing-Remitting Multiple Sclerosis cannot participate. Relapsing-Remitting Multiple Sclerosis is a form of the disease where symptoms flare up and then improve.
  • Patients who have had a recent infection or illness that could affect their immune system are not eligible.
  • Individuals with a history of severe allergic reactions to medications or vaccines are excluded.
  • Patients who are currently pregnant or breastfeeding cannot take part in the study.
  • Anyone with a history of cancer, except for certain types of skin cancer, is not allowed to participate.
  • Patients with significant heart problems or uncontrolled high blood pressure are excluded.
  • Individuals who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients who have received certain treatments for multiple sclerosis within a specific time frame before the study starts are excluded.
  • Anyone with a history of drug or alcohol abuse within the past year is not allowed to participate.
  • Patients with any other medical condition that the study doctors believe could interfere with the study results are excluded.
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Investigated drugs

  • Ocrelizumab

    is a medication used in this trial to treat children and adolescents with relapsing-remitting multiple sclerosis. It works by targeting specific cells in the immune system that are thought to play a role in the disease, helping to reduce the frequency of relapses.

  • Fingolimod

    is another medication being compared in this trial. It is also used to treat relapsing-remitting multiple sclerosis in children and adolescents. Fingolimod works by preventing certain immune cells from reaching the brain and spinal cord, which helps to reduce inflammation and the number of relapses.

What is already known about the treatment

  • Ocrelizumab

    Ocrelizumab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating relapsing-remitting multiple sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves. Ocrelizumab works by targeting and depleting specific immune cells called B cells, which are believed to play a role in the disease. It is classified as a monoclonal antibody, a type of medication designed to interact with specific proteins in the body.

  • Fingolimod

    Fingolimod is taken orally in the form of a capsule. It is an established treatment for relapsing-remitting multiple sclerosis, a disease characterized by episodes of neurological symptoms. Fingolimod works by trapping certain white blood cells in the lymph nodes, preventing them from reaching the brain and spinal cord where they could cause damage. It is classified as a sphingosine 1-phosphate receptor modulator, which helps reduce the frequency of relapses in patients.

Investigated diseases

Relapsing-Remitting Multiple Sclerosis – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During these 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. The disease progresses with these unpredictable relapses, which can vary in severity and duration. Over time, some individuals may experience a gradual worsening of symptoms, even during periods of remission. The exact cause of the disease is unknown, but it involves a combination of genetic and environmental factors. Symptoms can include fatigue, numbness, vision problems, and difficulties with coordination and balance.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-506516-40-00Protocol codeWN42086Estimated enrolment183 patientsSponsorF. Hoffmann-La Roche AG

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