This study focuses on people with Relapsing Multiple Sclerosis, a condition where the immune system attacks the protective covering of nerve cells, causing episodes of neurological symptoms. The study compares two medications: remibrutinib, a new oral medication that works by blocking a specific protein called Bruton’s tyrosine kinase, and ocrelizumab, an existing treatment that is given either through an infusion into a vein or as an injection under the skin.
The main purpose of this research is to determine if remibrutinib is as effective as ocrelizumab in controlling disease activity as seen on magnetic resonance imaging (MRI) scans. The study will look at patients who are currently using ocrelizumab and switch them to either continue ocrelizumab or start taking remibrutinib. The study will track participants’ progress for 24 months to compare how well both treatments work.
During the study, participants will receive either remibrutinib tablets taken by mouth or ocrelizumab given through injection or infusion. Doctors will monitor participants’ health through regular check-ups and MRI scans to track any changes in their condition. After the initial 24-month comparison period, all participants will have the opportunity to receive remibrutinib for an extended period.
1Initial screening and baseline assessment
A medical evaluation will be performed to confirm eligibility for the study
An MRI scan will be taken to establish baseline brain imaging
Your current multiple sclerosis status will be assessed
2Treatment assignment
You will be randomly assigned to receive either remibrutinib (taken as oral tablets) or continue ocrelizumab treatment
If assigned to remibrutinib, you will switch from your current ocrelizumab treatment to taking tablets by mouth
If assigned to ocrelizumab, you will continue receiving it through intravenous (into the vein) or subcutaneous (under the skin) injection
324-month main study period
Regular medical assessments will monitor your health status
MRI scans will track any changes in brain lesions
Your physical abilities will be evaluated to check for any changes in disability
Blood tests, vital signs checks, and heart monitoring (ECG) will be performed
Any symptoms or health changes will be recorded
4Extension period
After the main study period, you may continue in an extension phase
During this time, monitoring will continue with regular health assessments
MRI scans will continue to track brain lesions
Safety monitoring will include blood tests, vital signs, and heart activity checks
Who Can Join the Study?
Must sign an informed consent form before any study procedures begin
Must be 40 years or older at the time of screening
Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS) according to the 2017 McDonald criteria
Must be currently receiving treatment with ocrelizumab (a medication used to treat multiple sclerosis) at standard doses as part of regular medical care
Must be neurologically stable for at least 30 days before screening, which means:
No MS relapses (periods when symptoms get worse) during this time
No significant changes in neurological symptoms
Must be considered suitable by their doctor to switch to the study medication remibrutinib, or have a personal preference to make this change
Both men and women can participate in the study
Who Cannot Join the Study?
History of other neurological conditions besides multiple sclerosis
Current pregnancy or breastfeeding
Severe allergic reactions to similar medications in the past
Active serious infections, including hepatitis B or tuberculosis
Significant heart problems or uncontrolled high blood pressure
History of cancer in the past 5 years (except for successfully treated skin cancer)
Severe liver problems or abnormal liver function tests
Severe kidney problems or abnormal kidney function
Recent live vaccinations (within 6 weeks before starting treatment)
Current participation in other clinical trials
Inability to undergo MRI scans (magnetic resonance imaging – a type of medical imaging that uses magnetic fields)
History of drug or alcohol abuse within the past 6 months
Mental health conditions that could interfere with following study procedures
Taking medications that could interact with the study drug
Blood disorders or significant abnormalities in blood tests
Remibrutinib is a medication being studied for treating relapsing multiple sclerosis. It belongs to a class of drugs known as BTK inhibitors, which work by blocking specific proteins involved in inflammation. This medication aims to control the inflammatory activity in the brain and spinal cord of people with multiple sclerosis.
Ocrelizumab is an established medication used to treat relapsing multiple sclerosis. It works by targeting and reducing specific B cells in the immune system that are thought to contribute to nerve damage in multiple sclerosis. It is given through an intravenous infusion and is currently used as a standard treatment for multiple sclerosis.
Multiple Sclerosis (Relapsing) – A chronic neurological condition where the immune system attacks the protective covering of nerve fibers in the central nervous system. In the relapsing form, people experience distinct episodes of symptoms followed by periods of partial or complete recovery. During relapses, inflammation causes new damage to nerve cells, leading to various symptoms such as vision problems, muscle weakness, and coordination difficulties. Between relapses, patients may feel relatively well, though some symptoms might persist. The disease typically follows a pattern where new symptoms appear or existing ones worsen during relapses, which can last days to weeks.
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