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Study on Ofatumumab for Patients with Relapsing Multiple Sclerosis Transitioning from Fumarate-Based Therapies or Fingolimod

Verified siteRegistered drugNo placebo
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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 effectiveness of a treatment for relapsing multiple sclerosis (RMS), a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The treatment being tested is called Ofatumumab, which is given as an injection under the skin using a pre-filled pen. This study is designed to evaluate how well Ofatumumab works in patients who are transitioning from other RMS treatments, specifically those based on fumarate or a medication called Fingolimod.

The purpose of the study is to assess the effectiveness of Ofatumumab in patients who have experienced breakthrough disease activity, meaning their condition worsened despite being on previous treatments. Participants will receive Ofatumumab every four weeks over a period of 96 weeks. Throughout the study, researchers will monitor the annual relapse rate, which refers to the frequency of new attacks or worsening of symptoms. Additionally, the study will track any side effects, including reactions to the injections, and any changes in laboratory or vital signs results.

The study aims to provide valuable information on the effectiveness and safety of Ofatumumab for individuals with RMS who have not responded adequately to previous treatments. By understanding how this medication works in these patients, researchers hope to improve treatment options for those 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

    Joining the study

    Upon joining the study, the patient must have a diagnosis of relapsing multiple sclerosis (RMS) according to specific criteria. The patient should have a disability status with a score between 0 and 4 on a specific scale.

    The patient should have a history of using a maximum of three disease-modifying therapies (DMTs) and must be transitioning from fumarate-based therapies or fingolimod, having used them for at least six months.

  2. Step 2

    Initial assessment

    Before starting the treatment, the patient will undergo an initial assessment to confirm neurological stability within one month prior to the first administration of the study drug.

  3. Step 3

    Treatment administration

    The patient will receive ofatumumab, a medication administered as a 20 mg solution for injection. The injection is given under the skin (subcutaneous use) using a pre-filled pen.

    The medication is administered every four weeks throughout the study duration.

  4. Step 4

    Monitoring and evaluation

    The patient's progress will be monitored over a period of 96 weeks. The primary focus will be on the annual relapse rate, which is based on confirmed relapses.

    Secondary evaluations will include monitoring for any adverse events, changes in laboratory or vital signs, and any discontinuation of treatment due to lack of effectiveness or safety concerns.

  5. Step 5

    Completion of the study

    The study is expected to conclude by April 2025. At the end of the study, the effectiveness of the treatment and patient-reported outcomes will be evaluated.

Who can join the trial?

8 criteria

  • Must have a diagnosis of **MS** (Multiple Sclerosis) according to specific criteria from 2017.
  • Must have a type of **relapsing MS**, which includes relapsing forms and secondary progressive MS.
  • Must have a **disability status** with a score between 0 to 4 on a scale called the Expanded Disability Status Scale (EDSS).
  • Must have a history of using a maximum of 3 different **Disease Modifying Therapies (DMTs)**, with all types of fumarates counted as one.
  • Must be switching from a therapy based on fumarates, like dimethyl fumarate or diroximel fumarate, or from fingolimod, and must have used it for at least 6 months before starting the study medication.
  • Must have experienced **breakthrough disease activity** while properly using fumarates or fingolimod for at least 6 months. This means having one or more relapses or signs of activity on an **MRI** (Magnetic Resonance Imaging) scan, like new or growing lesions.
  • Must be **neurologically stable** for at least one month before starting the study medication.
  • Both **male and female** participants are eligible.

Who cannot join the trial?

8 criteria

  • Patients who do not have a diagnosis of relapsing multiple sclerosis (RMS) cannot participate. RMS is a type of multiple sclerosis where symptoms come and go.
  • Patients who have not experienced breakthrough disease while on fumarates or fingolimod cannot participate. Breakthrough disease means that the disease is still active despite treatment.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have a history of certain infections or diseases that could affect the study cannot participate.
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Investigated drugs

  • Ofatumumab

    is a medication used in this clinical trial to treat patients with relapsing multiple sclerosis (RMS). It is administered as an injection under the skin every four weeks. The purpose of using ofatumumab in this study is to evaluate its effectiveness in patients who have experienced disease progression despite being treated with other therapies. Ofatumumab works by targeting specific cells in the immune system that are involved in the disease process of multiple sclerosis.

  • Fumarate-based therapies

    are a group of medications previously used by patients in this trial before transitioning to ofatumumab. These therapies are designed to help manage relapsing multiple sclerosis by reducing inflammation and the frequency of relapses. They work by modulating the immune system to prevent it from attacking the nervous system.

  • Fingolimod

    is another medication that patients in this trial were using before switching to ofatumumab. It is an oral medication that helps control relapsing multiple sclerosis by preventing certain immune cells from reaching the brain and spinal cord, thereby reducing inflammation and the occurrence of relapses.

What is already known about the treatment

Ofatumumab – This medication is administered as a subcutaneous injection, typically given every four weeks. It is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis (RMS), particularly in patients who have not responded well to other treatments like fumarates or fingolimod. Ofatumumab works by targeting and depleting specific immune cells known as B cells, which are involved in the abnormal immune response seen in multiple sclerosis. It is classified as a monoclonal antibody, a type of medication designed to specifically target certain proteins in the body.

Investigated diseases

Relapsing Multiple Sclerosis – Relapsing multiple sclerosis (RMS) is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms, known as relapses. These relapses are followed by periods of partial or complete recovery, called remissions. The disease can cause a wide range of symptoms, including fatigue, vision problems, muscle weakness, and difficulties with coordination and balance. Over time, the frequency and severity of relapses may vary, and some individuals may experience a gradual worsening of symptoms. RMS is one of the most common forms of multiple sclerosis and can significantly impact daily life and activities. The exact cause of RMS is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507493-41-00Protocol codeCOMB157G23101Estimated enrolment453 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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