This study is being conducted to evaluate the effectiveness and safety of a medication called remibrutinib, also referred to by the code name LOU064, in individuals living with secondary progressive multiple sclerosis. This condition is a type of autoimmune disease where the body’s immune system attacks the protective covering of nerves, leading to a gradual worsening of physical and cognitive functions over time.
Participants in this trial will receive either the study drug, remibrutinib, in the form of a film-coated tablet taken by mouth, or a placebo. The purpose of the study is to determine if this treatment can help delay the progression of disability. During the study, individuals will be monitored over a period of time to observe how the medication affects their physical abilities and overall health.
Who Can Join the Study?
You must provide a signed informed consent, which is a formal document where you agree to join the study after understanding all the details.
You must be a man or a woman between the ages of 18 and 65 at the time of the initial screening.
You must have a diagnosis of secondary progressive multiple sclerosis (SPMS), which is a stage of multiple sclerosis where symptoms gradually worsen over time.
Your diagnosis must meet the 2017 revised McDonald criteria, which is a specific set of medical rules used by doctors to confirm a diagnosis of multiple sclerosis.
You must not have had any clinical relapses, which are sudden increases in symptoms or new neurological problems, in the 24 months before starting the study.
Your EDSS score must be between 3.0 and 6.0. The Expanded Disability Status Scale (EDSS) is a method used by doctors to measure how much disability a person with multiple sclerosis has.
There must be documented proof that your disability has progressed, meaning your physical limitations have become more noticeable or severe, within the 12 months before the screening.
Who Cannot Join the Study?
You are unwilling or unable to have MRI scans, which are detailed pictures of the inside of your body taken with a large magnet. This includes people with claustrophobia (an extreme fear of enclosed spaces) or those with metallic implants, metallic foreign bodies, pacemakers, or defibrillators (devices implanted in the chest to control heart rhythm) that make it unsafe to be near a strong magnet.
You have a history of serious central nervous system (CNS) disease, which refers to issues with the brain or spinal cord, such as a stroke, a traumatic brain or spinal injury, or myelopathy (damage to the spinal cord).
You have other neurological disorders (problems with the brain or nervous system) that might look like multiple sclerosis (MS) during the initial health check.
You are currently struggling with substance abuse, such as drugs or alcohol, or have a serious psychiatric condition (a mental health disorder) that might make it difficult for you to follow the study rules.
You have a history of, or show symptoms of, Progressive Multifocal Leukoencephalopathy (PML), which is a rare and serious infection that affects the brain.
You are a woman who is capable of becoming pregnant and are not using highly effective contraception (birth control methods with a failure rate of less than 1% per year) while taking the study medicine and for at least one week after stopping it.
You have a high bleeding risk or coagulation disorders, which are conditions that prevent your blood from clotting properly.
You are using any of the specific exclusionary medications (medicines that are not allowed for this study) listed in the study rules.
Remibrutinib is an oral tablet being tested to see if it can help slow down the progression of physical disability in people living with secondary progressive multiple sclerosis.
Secondary progressive multiple sclerosis – This is a form of multiple sclerosis characterized by a steady worsening of neurological functions over time. It typically follows an initial period of clearly defined attacks or episodes of neurological symptoms. Unlike other forms, the physical or cognitive impairments gradually increase without distinct periods of recovery. The progression involves ongoing damage to the protective covering of nerve fibers in the central nervous system. This damage can lead to difficulties with movement, coordination, and sensation.
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