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Study on Long-Term Safety and Effectiveness of Ofatumumab for Patients with Relapsing 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 long-term safety and effectiveness of a medication called ofatumumab in people with relapsing multiple sclerosis (RMS). Multiple sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. Ofatumumab is a type of medication known as a monoclonal antibody, which is designed to target specific cells in the immune system to help reduce the frequency of relapses in multiple sclerosis.

The purpose of this study is to evaluate how well ofatumumab is tolerated and how safe it is when used over a long period. Participants in the study will receive ofatumumab as an injection under the skin once every four weeks. The study will monitor participants for any side effects or changes in their health, including any changes in their laboratory test results or vital signs. The study will also track the number of relapses participants experience and any changes in their level of disability over time.

Participants will be followed for up to 240 weeks, which is about 4.5 years, to gather comprehensive data on the long-term effects of ofatumumab. The study aims to provide valuable information on the potential benefits and risks of using ofatumumab for managing relapsing multiple sclerosis, helping to inform future treatment options for this 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 participant will begin receiving the medication ofatumumab.

    The medication is administered as a subcutaneous injection every four weeks.

  2. Step 2

    Medication administration

    The participant will receive ofatumumab at a dose of 20 mg.

    This will continue every four weeks throughout the study duration.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will occur to assess safety and tolerability.

    This includes checking for any adverse events and monitoring laboratory results and vital signs.

  4. Step 4

    Long-term evaluation

    The study aims to evaluate the long-term safety and effectiveness of ofatumumab.

    Participants will be monitored for up to 240 weeks, which is approximately 4.5 years.

  5. Step 5

    End of study

    The study is expected to conclude in September 2028.

    Final assessments will be conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

6 criteria

  • The patient must have **relapsing multiple sclerosis (RMS)**, which is a type of multiple sclerosis where symptoms come and go.
  • The patient must have participated in a previous study by Novartis that involved taking a medication called **ofatumumab** at a dose of 20 mg under the skin every 4 weeks.
  • The patient must have been an adult, meaning they were 18 years or older, during the previous study on RMS.
  • The patient must have completed the previous study while still taking the study medication.
  • The patient must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other treatment for multiple sclerosis within the last month.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who have participated in another clinical trial within the last month.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any condition that affects their immune system.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have any condition that affects their ability to understand or follow study instructions.
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Investigated drugs

Ofatumumab is a medication used in this clinical trial to treat individuals with relapsing multiple sclerosis (RMS). It is administered as an injection under the skin once every four weeks. The purpose of this study is to assess the long-term safety, tolerability, and effectiveness of ofatumumab for patients with RMS.

What is already known about the treatment

Ofatumumab – This medication is administered as a subcutaneous injection, typically given once every four weeks. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating relapsing multiple sclerosis (RMS). 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 drug designed to interact with specific proteins in the body to modify the immune system's activity.

Investigated diseases

Relapsing Multiple Sclerosis (RMS) – Relapsing multiple sclerosis is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease can lead to symptoms such as fatigue, difficulty walking, numbness, and vision problems. Over time, the frequency and severity of relapses may vary, and some individuals may experience a gradual worsening of symptoms. The exact cause of RMS is not fully understood, but it involves an immune system attack on the protective covering of nerves. This damage disrupts communication between the brain and the rest of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507906-15-00Protocol codeCOMB157G2399Estimated enrolment1 894 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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