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Study Comparing the Effects of Ozanimod and Fingolimod in 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 called Relapsing Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where patients experience episodes of new or worsening symptoms followed by periods of recovery. The study will compare the effectiveness and safety of two oral medications: Ozanimod and Fingolimod. Ozanimod is being tested in different doses, including 0.23 mg, 0.0575 mg, 0.25 mg, and 1 mg, and is also known by the code name RPC1063. Fingolimod is another medication used to treat RRMS.

The purpose of the study is to determine if Ozanimod is effective compared to Fingolimod in treating children and adolescents with RRMS. Participants will take either Ozanimod, Fingolimod, or a placebo. The study will monitor the rate of MS relapses over a period of two years and will also look at the overall health and any side effects experienced by the participants. The study will include a core phase and an extension phase, where participants who complete the core phase may continue to be monitored in the extension phase.

Throughout the study, participants will undergo regular check-ups to assess their condition and the amount of Ozanimod in their bodies. The study aims to provide valuable information on the safety and effectiveness of these treatments for RRMS in young patients. The estimated end date for the study is July 3, 2036.

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

    Joining the study

    Upon joining the study, the participant is diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).

    The participant must have experienced at least one MS relapse in the previous year or two relapses in the past two years, or show evidence of growth in an MRI within six months.

    The participant's Expanded Disability Status Scale (EDSS) score should be between 0 and 5.5.

    The participant must be able to swallow capsules.

  2. Step 2

    Core phase

    The core phase involves taking medication to assess the rate of MS relapse over two years.

    Participants will receive either Ozanimod or Fingolimod orally.

    Ozanimod is administered in different dosages: 0.23 mg, 1 mg, 0.0575 mg, and 0.25 mg in sprinkle or hard capsule form.

    Fingolimod is available in 0.25 mg and 0.5 mg hard capsules.

    The primary goal is to compare the effectiveness of Ozanimod against Fingolimod.

  3. Step 3

    Monitoring and assessment

    Throughout the core phase, the participant's condition is monitored to assess the proportion of those with worsening or improving RRMS.

    The occurrence of any adverse events, including their type, severity, and relationship to the study drug, is recorded.

    Measurements of the amount of Ozanimod in the participant's body are taken.

  4. Step 4

    Extension phase

    Participants who complete the core phase may enter the extension phase.

    The extension phase continues to monitor the participant's condition and any adverse events.

    The study aims to gather long-term data on the safety and effectiveness of the medications.

  5. Step 5

    Completion

    The study is estimated to end by July 3, 2036.

    Participants' data will contribute to understanding the long-term effects and safety of Ozanimod and Fingolimod in treating RRMS.

Who can join the trial?

7 criteria

  • Must have a diagnosis of **Relapsing Remitting Multiple Sclerosis (RRMS)**, which is a type of multiple sclerosis where symptoms come and go.
  • Must have had at least one **MS relapse** (a return of symptoms) in the past year, or two relapses in the past two years, or show evidence of new growths in the brain on an **MRI** (a type of scan) within the last six months.
  • Must have a score between 0 and 5.5 on the **Expanded Disability Status Scale (EDSS)**, which is a way to measure how much MS affects your daily life.
  • Must be able to swallow a capsule.
  • Must complete the initial part of the study to join the extension phase.
  • Both males and females can participate.
  • Participants can be from vulnerable populations, which means they might need extra protection or care.
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Investigated drugs

  • Ozanimod

    is a medication being tested to see if it is effective in treating children and adolescents with relapsing-remitting multiple sclerosis (RRMS). It is taken orally and works by modulating the immune system to reduce the frequency of relapses and slow the progression of the disease.

  • Fingolimod

    is another medication used to treat relapsing-remitting multiple sclerosis. It is also taken orally and helps to control the disease by preventing certain immune cells from reaching the brain and spinal cord, which can reduce inflammation and nerve damage. In this study, it is used as a comparison to evaluate the effectiveness of ozanimod.

What is already known about the treatment

  • Ozanimod

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Relapsing Remitting Multiple Sclerosis (RRMS). It is classified as a sphingosine 1-phosphate receptor modulator, which works by blocking certain receptors on lymphocytes, preventing them from leaving the lymph nodes and reducing inflammation in the central nervous system. Ozanimod is being compared to another medication, Fingolimod, to evaluate its safety, efficacy, and tolerability in children and adolescents with RRMS.

  • Fingolimod

    This medication is also taken orally and is already approved for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). It belongs to the same pharmacological class as Ozanimod, acting as a sphingosine 1-phosphate receptor modulator. Fingolimod works by trapping lymphocytes in the lymph nodes, which helps reduce the immune system's attack on the central nervous system. It is being used as a comparator in clinical trials to assess the effectiveness of Ozanimod in younger populations with RRMS.

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 a relapse, individuals may experience symptoms such as fatigue, numbness, vision problems, or difficulty with coordination and balance. These symptoms can vary in severity and duration. After a relapse, there is a remission phase where symptoms may improve or disappear entirely. Over time, some people may experience a gradual worsening of symptoms, even between relapses. The disease progression can be unpredictable, with varying patterns of relapses and remissions.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501332-42-00Protocol codeIM047-050Estimated enrolment78 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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