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Study on the Effects of a Higher Dose of Ocrelizumab for Adults 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 effects of a higher dose of Ocrelizumab in adults with Relapsing Multiple Sclerosis (MS). Multiple Sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, which can lead to various neurological problems. The study aims to determine if a higher dose of Ocrelizumab is more effective than the currently approved dose in reducing the progression of disability in people with this type of MS.

Participants in the study will receive either the higher dose of Ocrelizumab, the approved dose, or a placebo. Ocrelizumab is administered as a solution for infusion, which means it is given through a vein. The study will monitor participants over a period to assess the impact of the treatment on their condition. The goal is to see if the higher dose can better prevent the worsening of symptoms compared to the standard dose.

Throughout the study, various health indicators will be tracked, including changes in brain volume, levels of certain proteins in the blood, and the number of specific immune cells. The study will also evaluate the safety of the higher dose by monitoring any side effects. This research is important for understanding how to better manage Relapsing Multiple Sclerosis and improve the quality of life for those affected by 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a neurological examination.

    An MRI scan of the brain is performed to check for abnormalities consistent with multiple sclerosis.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is conducted to establish a starting point for the study. This includes measuring the Expanded Disability Status Scale (EDSS) score, which assesses disability in multiple sclerosis.

    Blood samples are taken to measure B-cell levels and other relevant biomarkers.

  3. Step 3

    Treatment initiation

    The treatment phase begins with the administration of ocrelizumab through an intravenous infusion. The dosage is 300 mg, and the infusion is repeated every six months.

    Before each infusion, methylprednisolone (500 mg) is administered intravenously to reduce the risk of infusion-related reactions.

    Diphenhydramine hydrochloride (50 mg) and paracetamol (500 mg) are taken orally before each infusion to help manage potential side effects.

  4. Step 4

    Ongoing monitoring

    Regular follow-up visits are scheduled to monitor health and response to treatment. These visits include physical examinations and blood tests to measure B-cell levels and other markers.

    The study aims to assess the time to onset of confirmed disability progression, which is monitored through various tests and assessments.

  5. Step 5

    End of study evaluation

    At the end of the study period, a final evaluation is conducted. This includes a comprehensive assessment of disability progression and any changes in brain volume.

    The final visit includes a review of any side effects experienced during the study and a summary of the overall health status.

Who can join the trial?

6 criteria

  • Must be between 18 and 55 years old at the time of screening.
  • Must have a diagnosis of **Relapsing Multiple Sclerosis (RMS)**. This includes **Relapsing-Remitting Multiple Sclerosis (RRMS)** or **Active Secondary Progressive Multiple Sclerosis (aSPMS)**, where patients still experience relapses. The diagnosis should follow the revised McDonald Criteria from 2017.
  • Must have had at least two documented clinical relapses in the last 2 years before screening, or one clinical relapse in the year before screening. There should be no relapse 30 days before screening and at the start of the study.
  • Must be neurologically stable, meaning no significant changes in their neurological condition, for at least 30 days before randomization and baseline assessments.
  • Must have an **Expanded Disability Status Scale (EDSS)** score between 0 and 5.5, inclusive, at screening and baseline. The EDSS is a method of measuring disability in people with Multiple Sclerosis.
  • Must have a documented **MRI** (Magnetic Resonance Imaging) of the brain showing abnormalities that are consistent with Multiple Sclerosis.

Who cannot join the trial?

8 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 or antiviral medications.
  • Patients who have received any other treatment for **Multiple Sclerosis (MS)** within a certain period before the study.
  • Patients who have a history of severe allergic reactions to any medications.
  • Patients who have participated in another clinical trial within a certain period before this study.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.
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Investigated drugs

Ocrelizumab is a medication used in this clinical trial to treat adults with relapsing multiple sclerosis. The study aims to compare the effects of a higher dose of ocrelizumab with the currently approved dose. The goal is to see if the higher dose can better reduce the risk of disability progression in patients.

What is already known about the treatment

Ocrelizumab – Ocrelizumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently approved and widely used in the treatment of relapsing forms of multiple sclerosis (MS), with ongoing research to evaluate higher doses for improved efficacy. The medication works by targeting and depleting CD20-positive B cells, which are believed to play a role in the abnormal immune response seen in MS. Ocrelizumab is classified as a monoclonal antibody, specifically designed to modulate the immune system and reduce inflammation associated with MS.

Investigated diseases

Relapsing Multiple Sclerosis – Relapsing Multiple Sclerosis (MS) is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by episodes of new or worsening neurological symptoms, known as relapses, followed by periods of partial or complete recovery. These relapses can involve symptoms such as fatigue, difficulty walking, numbness, and vision problems. Over time, the disease can lead to a gradual decline in neurological function. The progression of the disease varies among individuals, with some experiencing frequent relapses and others having long periods of stability. The exact cause of MS is unknown, but it is believed to involve an abnormal immune response that damages the protective covering of nerve fibers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506467-34-00Protocol codeBN42082Estimated enrolment864 patientsSponsorF. Hoffmann-La Roche AG

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