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A Study Comparing Two Forms of Ocrelizumab Given Under the Skin in Patients with Multiple Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted in patients with Multiple Sclerosis, which is a condition where the body's immune system attacks the protective covering of nerves, leading to problems with movement, vision, and other body functions. The treatment being tested is ocrelizumab, which is a medicine that works by affecting certain cells in the immune system to help slow down the disease. In this study, two different formulations of ocrelizumab given under the skin will be compared, one called the test formulation and one called the reference formulation.

The purpose of this study is to determine if the test formulation of ocrelizumab works in the body in the same way as the reference formulation. During the study, participants will receive injections of ocrelizumab under the skin and will be monitored over a period of time. The study will measure how much of the medicine is in the blood and how long it stays there by taking blood samples at different times. The study will also check for any unwanted effects of the treatment and will monitor changes in vital signs, which are basic body measurements like blood pressure and heart rate, as well as results from laboratory tests of blood and other samples.

Participants will be randomly assigned to receive either the test or reference formulation of the medicine. The study is described as open-label, which means that both the participants and the doctors will know which formulation is being given. The treatment period will last for several months, and participants will be followed to collect information about how the medicine affects their body and their overall health.

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

    Enrollment and randomization

    Upon joining the study, you will be randomly assigned to one of two groups. Each group will receive a different subcutaneous formulation of ocrelizumab. Subcutaneous means the medication is injected under the skin.

    This is an open-label study, which means both you and your doctor will know which formulation you are receiving.

  2. Step 2

    Treatment administration

    You will receive ocrelizumab injections under the skin. The dose is 920 mg per injection.

    The specific schedule and frequency of injections will be determined by the study protocol and explained to you by the study staff.

    The treatment will be administered at the study site.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your condition will be monitored regularly. This includes assessments of your Expanded Disability Status Scale score, which measures the level of disability in multiple sclerosis.

    Blood samples will be collected at specified times to measure the amount of ocrelizumab in your blood. This helps determine how your body processes the medication.

    Your vital signs will be measured, including blood pressure, heart rate, and temperature. Changes from your initial measurements will be recorded.

    Clinical laboratory tests will be performed, which may include blood and urine tests. Changes from your initial test results will be monitored.

  4. Step 4

    Safety monitoring

    Any adverse events will be recorded throughout the study. Adverse events are any unwanted or harmful effects that occur during treatment.

    The severity of any adverse events will be assessed using a standardized grading scale.

    Your safety will be continuously monitored during the entire treatment period.

  5. Step 5

    Study completion

    The study is expected to continue until December 2029.

    After receiving your final dose of ocrelizumab, you will be followed for an additional 6 months.

    Final assessments will be completed at the end of your participation in the study.

Who can join the trial?

5 criteria

  • You must be between 18 and 65 years old at the time you sign the consent form to join the study
  • You must have a diagnosis of relapsing multiple sclerosis (a form of multiple sclerosis where symptoms come and go) or primary progressive multiple sclerosis (a form where symptoms gradually worsen from the beginning) according to specific medical criteria from 2017 or the most recent criteria when the study begins
  • Your EDSS score (a scale that measures how much multiple sclerosis affects your ability to walk and perform daily activities, ranging from 0 to 10) must be between 0 and 6.5 at the time of screening
  • If you are a woman who can become pregnant, you must agree to either not have sexual intercourse with men or use reliable birth control methods during the study and for 6 months after receiving the last dose of the study medication
  • If you are a woman who cannot become pregnant, you may join the study if you have gone through menopause (the natural end of menstrual periods that happens with aging)

Who cannot join the trial?

7 criteria

  • The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this document
  • Generally, patients should discuss their full medical history with the study doctor to determine if they are suitable for this trial
  • Certain health conditions, medications, or treatments may prevent participation, but these specific details are not included in the available information
  • Women who are pregnant or breastfeeding (feeding a baby with breast milk) are typically not allowed to participate in clinical trials like this one
  • Patients with serious infections or weakened immune systems (the body's natural defense against disease) may not be eligible
  • People who have had severe allergic reactions to similar medications in the past may be excluded
  • Patients currently participating in another clinical trial may not be able to join this study
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Investigated drugs

Ocrelizumab is a medicine used to treat multiple sclerosis, which is a disease that affects the brain and spinal cord. In this study, two different versions of ocrelizumab given by injection under the skin will be compared to see if they work the same way in the body.

What is already known about the treatment

Ocrelizumab – Ocrelizumab is a medication administered through subcutaneous injection, which means it is given as a shot under the skin, used for treating Multiple Sclerosis, a disease where the body's immune system attacks the protective covering of nerves. This medicine works by targeting and reducing specific immune cells called B-cells that are responsible for damaging the nervous system in MS patients. Ocrelizumab belongs to a class of drugs known as monoclonal antibodies, which are laboratory-made proteins that can bind to specific targets in the body to modify immune system activity.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease of the central nervous system that affects the brain and spinal cord. The immune system mistakenly attacks the protective covering of nerve fibers called myelin, causing communication problems between the brain and the rest of the body. This damage creates scar tissue, which gives the disease its name. The disease can cause various symptoms including numbness, weakness, vision problems, difficulty walking, and problems with coordination and balance. Symptoms may come and go in episodes called relapses, or they may gradually worsen over time. The pattern and severity of symptoms vary greatly from person to person depending on which nerves are affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517980-22-00Protocol codeCN45320Estimated enrolment182 patientsSponsorF. Hoffmann-La Roche AG

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