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Study on the Effectiveness and Safety of Fenebrutinib and 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). PPMS is a type of multiple sclerosis where symptoms gradually worsen over time without relapses. The study aims to compare the effectiveness and safety of two treatments: Fenebrutinib and Ocrelizumab. Fenebrutinib is taken as a film-coated tablet, while Ocrelizumab is administered as a solution for infusion, which means it is given through a vein.

The purpose of the study is to evaluate how well Fenebrutinib works compared to Ocrelizumab in treating adults with PPMS. Participants in the study will receive either Fenebrutinib, Ocrelizumab, or a placebo, which is a substance with no active medication. The study will follow participants over a period of time to observe any changes in their condition and to monitor for any side effects. The study will also look at various health measures, such as changes in brain volume using MRI scans and levels of certain proteins in the blood.

Throughout the study, participants will have regular check-ups to assess their health and the progression of their symptoms. The study will help determine which treatment is more effective in managing PPMS and provide valuable information on the safety of these medications. This research is important for improving treatment options for people living with PPMS.

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

    The study begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

    Eligibility criteria include a diagnosis of primary progressive multiple sclerosis (PPMS) and an EDSS score between 3.0 and 6.5.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either fenebrutinib or ocrelizumab. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    If assigned to ocrelizumab, the participant receives an intravenous infusion of Ocrevus 300 mg at specified intervals.

    If assigned to fenebrutinib, the participant takes oral tablets as directed by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the participant's health and response to treatment. This includes physical exams, MRI scans, and blood tests.

    Participants are evaluated for any changes in disability progression and other health indicators.

  5. Step 5

    Completion of study

    The study is expected to conclude in May 2028. At the end of the study, final assessments are conducted to evaluate the overall efficacy and safety of the treatments.

Who can join the trial?

6 criteria

  • Ability to follow the study plan and instructions.
  • Have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) according to the updated 2017 McDonald Criteria. This means the patient has a specific type of multiple sclerosis that progresses over time.
  • Experienced worsening of disability in the 12 months before the study starts, as measured by a special questionnaire.
  • Have an EDSS score between 3.0 and 6.5 at the start of the study. The EDSS score is a way to measure how much the disease affects the patient's ability to move and perform daily activities.
  • Have a pyramidal functional subscore of 2 or higher at the start of the study. This score relates to muscle strength and movement abilities.
  • If currently taking medications called proton pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs), the patient must be on a stable dose before and during the study. These medications are often used to reduce stomach acid.

Who cannot join the trial?

7 criteria

  • Patients who do not have Primary Progressive Multiple Sclerosis (PPMS) cannot participate. PPMS is a type of multiple sclerosis where symptoms gradually worsen over time.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients with certain other medical conditions or who are taking certain medications that might interfere with the study cannot participate. These conditions or medications are not specified here.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have a history of certain serious health issues, such as heart problems or severe infections, may not be eligible to participate.
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Investigated drugs

  • Fenebrutinib

    is a medication being studied for its potential to treat primary progressive multiple sclerosis (PPMS). It works by targeting specific proteins in the body that are involved in the immune response, which may help reduce inflammation and slow the progression of the disease.

  • Ocrelizumab

    is an existing treatment for primary progressive multiple sclerosis. It is a type of medication known as a monoclonal antibody, which targets and reduces certain immune cells that are believed to contribute to the damage of nerve cells in multiple sclerosis. This can help slow the progression of the disease and manage symptoms.

What is already known about the treatment

  • Fenebrutinib

    Fenebrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating Primary Progressive Multiple Sclerosis (PPMS). It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for fenebrutinib is PPMS, a form of multiple sclerosis characterized by a gradual worsening of neurological function. Fenebrutinib works by inhibiting a specific enzyme called Bruton's tyrosine kinase (BTK), which plays a role in the immune system's activity. It is classified as a BTK inhibitor, a type of medication that targets specific pathways involved in immune responses.

  • Ocrelizumab

    Ocrelizumab is administered through intravenous infusion and is an established treatment for Primary Progressive Multiple Sclerosis (PPMS). It is approved for use in medical practice and is supported by medical literature for its effectiveness in managing PPMS. The main therapeutic indication for ocrelizumab is PPMS, where it helps slow the progression of disability. Ocrelizumab works by targeting and depleting certain 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 and neutralize certain proteins in the body.

Investigated diseases

Primary Progressive Multiple Sclerosis – 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. It primarily affects the spinal cord and brain, leading to increasing disability over time. Symptoms may include problems with walking, muscle stiffness, and weakness. Unlike other forms of multiple sclerosis, this type does not have periods of recovery, making the progression more continuous. The disease can vary greatly in its impact, with some individuals experiencing more severe symptoms than others. It is a chronic condition that affects the central nervous system, leading to a range of physical and cognitive challenges.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502611-10-00Protocol codeGN41791Estimated enrolment985 patientsSponsorF. Hoffmann-La Roche AG

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