This study is looking at progressive forms of multiple sclerosis, a condition where the nervous system becomes damaged over time, leading to worsening disability. The study will test a medication called RO7268489, which is given as a capsule by mouth, in combination with another medication called ocrelizumab, which is given through a vein. Some people in the study will receive RO7268489 while others will receive placebo. The purpose of this study is to see if RO7268489 can slow down the worsening of disability in people with progressive multiple sclerosis who are already taking ocrelizumab.
During the study, people will receive different doses of RO7268489 or placebo in addition to their regular ocrelizumab treatment. The study will look at how well the medication works by checking if disability gets worse over time. This will be measured by looking at walking ability, hand function, and thinking skills. The study will also check how safe the medication is by watching for any unwanted effects and by doing regular health checks including blood tests and heart monitoring.
People taking part will need to wear a device that measures how they walk. The study will also measure the levels of certain substances in the blood to understand how the medication works in the body. The study will last for several years and will compare the results between people taking RO7268489 and those taking placebo to determine if the medication is helpful in slowing down the progression of multiple sclerosis.
1Treatment assignment and medication start
After joining the study, you will be randomly assigned to one of several treatment groups. This process is called randomization and determines whether you will receive RO7268489 at a specific dose or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredients.
All participants will continue receiving ocrelizumab (brand name Ocrevus) during the study. Ocrelizumab is given as an infusion, which means it is delivered directly into your vein through a needle over a period of time.
In addition to ocrelizumab, you will take either RO7268489 or placebo in the form of hard capsules that you swallow by mouth. The study is double-blind, meaning neither you nor your doctor will know which treatment you are receiving.
2Regular medication administration
You will take the assigned capsules (either RO7268489 or placebo) orally on a regular schedule as instructed by the study team.
You will continue receiving ocrelizumab infusions according to the standard treatment schedule throughout the study period.
The study will continue until approximately May 2030, though your individual participation duration may vary.
3Physical function assessments
During the study, you will undergo regular assessments to measure your physical abilities and any changes in your condition.
You will be asked to complete the Timed 25-Foot Walk Test, which measures how long it takes you to walk a distance of 25 feet.
You will also perform the 9-Hole Peg Test, which assesses your hand coordination and dexterity by measuring how quickly you can place nine pegs into holes.
Your overall disability level will be evaluated using the Expanded Disability Status Scale, a standard measure used to assess the degree of disability in multiple sclerosis.
4Cognitive function testing
You will complete the Symbol Digit Modalities Test at regular intervals. This test measures your cognitive processing speed and involves matching symbols to numbers as quickly as possible.
The test helps assess whether there are any changes in your thinking and information processing abilities over time.
5Digital gait monitoring
You will be required to wear a digital gait assessment device according to the study schedule. This device tracks your walking patterns and movement.
The device provides objective information about your mobility and any changes that may occur during the study.
6Blood sample collection
Blood samples will be collected at scheduled visits throughout the study.
These samples will be used to measure the levels of RO7268489 and its breakdown products in your blood.
The samples will also measure levels of a substance called 2-arachidonoylglycreol (2-AG), which is a natural compound in your body that the study medication affects.
Standard laboratory tests will be performed to monitor your overall health and safety.
7Safety monitoring
At each study visit, you will be asked about any health problems or side effects you have experienced since your last visit.
Your vital signs, such as blood pressure, heart rate, and temperature, will be measured regularly.
You will have electrocardiograms (ECGs) performed at scheduled times. An ECG is a test that records the electrical activity of your heart.
You will complete the Columbia-Suicide Severity Rating Scale, a questionnaire that asks about thoughts of self-harm. This is a standard safety measure in clinical studies.
8Ongoing study participation
You will continue with regular study visits throughout the treatment period.
The study will monitor whether your disability progresses over time. Disability progression is defined as a worsening of your condition that is confirmed at visits separated by at least 12 or 24 weeks, depending on the measure being used.
The study is expected to continue until approximately May 2030, though your individual participation may end earlier or later depending on various factors.
Who Can Join the Study?
You must be between 18 and 60 years old at the time you sign the consent form to join the study
You must have progressive multiple sclerosis, which is a form of the disease where symptoms gradually worsen over time, confirmed according to specific medical guidelines from 2017
Your EDSS score must be between 3.0 and 6.0 at the screening visit. EDSS stands for Expanded Disability Status Scale, which is a way doctors measure how much multiple sclerosis affects your ability to walk and perform daily activities
You must have documented proof that your disability has gotten worse over the past 2 years before the screening visit, and this worsening must have happened regardless of whether you had any relapses. A relapse is a sudden worsening of symptoms that happens for a short period of time
If you took ocrelizumab in the past, which is a medication used to treat multiple sclerosis, and stopped taking it more than 2 years before screening, you can still participate. However, the reason you stopped must not have been due to safety problems or because the medication did not work. Also, your B cell count must be normal at screening. B cells are a type of white blood cell that are part of your immune system
You must agree to wear a digital gait assessment device as required by the study. This is a device that measures how you walk and move
Who Cannot Join the Study?
The source data does not contain specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed information about who cannot join this study, it is not possible to list the specific conditions or situations that would prevent participation
Generally, clinical trials have exclusion criteria to ensure patient safety and the accuracy of study results, but these specific details are not provided in the available information
RO7268489 is an investigational medication being tested as an add-on treatment for people with progressive forms of multiple sclerosis who are already receiving ocrelizumab. This medication works by blocking an enzyme called monoacylglycerol lipase. The study will look at whether adding this medication to the current treatment can help slow down the worsening of disability in people with progressive multiple sclerosis.
Ocrelizumab is a medication used to treat multiple sclerosis. In this study, all participants will already be receiving this medication as their current treatment. The study is testing whether adding RO7268489 to ocrelizumab works better than ocrelizumab alone in preventing the disease from getting worse.
Progressive Multiple Sclerosis – Progressive Multiple Sclerosis is a form of multiple sclerosis where neurological function gradually worsens over time. This condition affects the central nervous system, including the brain and spinal cord. The immune system attacks the protective covering of nerve fibers, causing communication problems between the brain and the rest of the body. Unlike other forms of multiple sclerosis, progressive forms show a steady decline in function rather than distinct attacks followed by recovery periods. People with this condition may experience increasing difficulty with walking, coordination, and physical movements. Cognitive functions, including processing speed and memory, may also decline as the disease progresses.
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