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Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive 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 Primary Progressive Multiple Sclerosis (PPMS). This is a type of multiple sclerosis where symptoms gradually worsen over time without any periods of improvement. The study is evaluating a treatment called Ocrelizumab, which is given as an infusion, meaning it is administered directly into the bloodstream through a vein. The trial aims to determine if a higher dose of Ocrelizumab is more effective than the currently approved dose in slowing down the progression of disability in people with PPMS.

Participants in the study will receive either the higher dose of Ocrelizumab, the approved dose, or a placebo. The study will monitor the participants over a period to see how the treatment affects their condition. The main goal is to see if the higher dose can better reduce the risk of disability progression, which is a measure of how the disease affects a person's ability to perform daily activities. The study will also look at other factors, such as changes in brain volume and levels of certain proteins in the blood that are related to nerve damage.

In addition to Ocrelizumab, some participants may receive other medications like Paracetamol, Methylprednisolone, and Diphenhydramine Hydrochloride to manage symptoms or side effects. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The trial will continue until the researchers have enough information to determine the effectiveness and safety of the higher dose of Ocrelizumab for treating PPMS.

The research process

The trial runs in 6 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 verifying age, diagnosis of primary progressive multiple sclerosis (PPMS), and other criteria such as neurological stability and MRI results.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to assess the current status of the condition. This includes the expanded disability status scale (EDSS) score and other functional assessments.

  3. Step 3

    Medication administration

    The study involves the administration of ocrelizumab through intravenous infusion. The dosage and frequency are determined by the study protocol.

    Additional medications include paracetamol 500 mg tablets taken orally, methylprednisolone 500 mg for injection or infusion, and diphenhydramine hydrochloride 50 mg tablets taken orally or intravenously as needed.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor the effects of the medication and assess any changes in the condition. These visits include clinical evaluations and laboratory tests.

  5. Step 5

    Progress evaluation

    The primary goal is to evaluate the time to onset of confirmed disability progression (cCDP) sustained for at least 12 weeks. Secondary evaluations include various other measures of disease progression and response to treatment.

  6. Step 6

    End of study assessments

    At the end of the study period, final assessments are conducted to evaluate the overall impact of the treatment on the condition. This includes a comprehensive review of all collected data and outcomes.

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 Primary Progressive Multiple Sclerosis (PPMS) according to the revised McDonald criteria from 2017. This is a set of guidelines used to diagnose multiple sclerosis.
  • Must have an Expanded Disability Status Scale (EDSS) score between 3 and 6.5 at screening and baseline. The EDSS is a method of measuring disability in people with multiple sclerosis.
  • Must have a score of 2.0 or higher on the Functional Systems (FS) scale for the pyramidal system, which is related to findings in the lower body, at screening and baseline. The FS scale is used to assess different functions of the nervous system.
  • Must have a documented MRI of the brain showing abnormalities that are consistent with multiple sclerosis. An MRI is a type of scan that creates detailed images of the inside of the body.
  • Must be neurologically stable for at least 30 days before the start of the study and baseline assessments. This means there should be no significant changes in neurological condition during this period.

Who cannot join the trial?

10 criteria

  • Patients with any other type of multiple sclerosis besides Primary Progressive Multiple Sclerosis (PPMS) cannot participate. PPMS is a form of multiple sclerosis where symptoms gradually worsen over time.
  • Patients who have had a recent infection or are currently experiencing an infection are not eligible.
  • Individuals with a history of cancer, except for certain types of skin cancer, are excluded.
  • Patients with significant heart problems, such as heart failure or recent heart attack, cannot join the study.
  • People with severe liver disease are not eligible to participate.
  • Patients who have received certain treatments for multiple sclerosis in the past may be excluded.
  • Individuals who are pregnant or breastfeeding cannot take part in the trial.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Anyone with a known allergy to the study medication or its ingredients cannot participate.
  • Patients with a history of drug or alcohol abuse may be excluded from the study.
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Investigated drugs

Ocrelizumab: This medication is used in the treatment of multiple sclerosis, specifically for adults with primary progressive multiple sclerosis. The trial is investigating whether a higher dose of ocrelizumab is more effective than the currently approved dose in reducing the risk of disability progression. Ocrelizumab works by targeting specific cells in the immune system that are thought to contribute to the damage of nerve cells in multiple sclerosis.

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 for use in treating Primary Progressive Multiple Sclerosis (PPMS) and is being studied in clinical trials to evaluate the efficacy of a higher dose. The medication works by targeting and depleting specific B cells, which are part of the immune system and play a role in the progression of multiple sclerosis. Ocrelizumab is classified as a monoclonal antibody, and its mechanism involves binding to the CD20 protein on the surface of B cells, leading to their destruction.

Investigated diseases

Primary Progressive Multiple Sclerosis (PPMS) – This is a form of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. Unlike other types of multiple sclerosis, PPMS does not have clear episodes of attacks or recovery. The disease primarily affects the spinal cord and brain, leading to symptoms such as muscle weakness, difficulty walking, and problems with balance and coordination. Over time, individuals may experience increasing disability, with symptoms progressively worsening. The progression of PPMS can vary significantly among individuals, with some experiencing a steady decline and others having periods of stability.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506515-18-00Protocol codeBN42083Estimated enrolment769 patientsSponsorF. Hoffmann-La Roche AG

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