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Study on the Safety and Efficacy of BIIB091 and Diroximel Fumarate for Patients with Relapsing 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 the safety and effectiveness of a new treatment for people with relapsing forms of Multiple Sclerosis (MS). Multiple Sclerosis is a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The study will test a medication called BIIB091, both on its own and in combination with another medication called Diroximel Fumarate (also known as Vumerity). These medications are being tested to see how well they work in reducing inflammation in the central nervous system, which is a key feature of MS.

The trial is divided into two parts. In the first part, participants will receive BIIB091 by itself to assess its safety and how well it is tolerated. In the second part, participants will receive a combination of BIIB091 and Diroximel Fumarate, or Diroximel Fumarate alone, to compare the effects on brain inflammation as seen on MRI scans. MRI, or Magnetic Resonance Imaging, is a technique used to create detailed images of the organs and tissues in the body, which helps in monitoring the disease's activity.

Participants in the study will be randomly assigned to different treatment groups, and the study will be conducted in a way that neither the participants nor the researchers know which treatment is being given, to ensure unbiased results. The study will last for a period of up to 48 weeks for each participant, during which they will receive regular check-ups and monitoring to ensure their safety and to gather data on the effectiveness of the treatments. The goal is to find a treatment that can help manage the symptoms of relapsing forms of Multiple Sclerosis more effectively.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and screening
Upon joining the study, you will attend an initial visit where medical history and current health status are reviewed. This includes a physical examination and various tests to ensure eligibility for the trial.
You will undergo a brain MRI scan to check for specific types of lesions. This helps confirm the diagnosis of relapsing forms of multiple sclerosis.
Step 2
Randomization and treatment assignment
After eligibility is confirmed, you will be randomly assigned to one of the treatment groups. This means you will receive either BIIB091 alone or in combination with Diroximel Fumarate.
The study does not include a placebo group, so all participants will receive active treatment.
Step 3
Treatment phase part 1
In the first part of the treatment phase, you will take BIIB091 in tablet form. The dosage and frequency will be explained by the study team.
Regular check-ups will be scheduled to monitor your health and any side effects. You will also have periodic MRI scans to assess brain inflammation.
Step 4
Treatment phase part 2
In the second part of the treatment phase, you may continue with BIIB091 or receive a combination of BIIB091 and Diroximel Fumarate.
You will take Diroximel Fumarate as gastro-resistant capsules. The study team will provide instructions on dosage and frequency.
Step 5
Ongoing monitoring
Throughout the trial, you will have regular visits to monitor your health, including blood tests and heart monitoring.
You will be asked to report any side effects or changes in your condition. This information is crucial for assessing the safety and effectiveness of the treatments.
Step 6
End of study procedures
At the end of the study, you will have a final visit to assess your overall health and any changes since the start of the trial.
The study team will discuss the results with you and provide guidance on next steps for your treatment and care.

Who can join the trial?

7 criteria

Must have a diagnosis of Relapsing Forms of Multiple Sclerosis (RMS). This includes relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS) according to the 2017 Revised McDonald criteria.
Time since the onset of multiple sclerosis symptoms must be less than 20 years.
Must have an Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at the start of the study. The EDSS is a method of measuring disability in people with multiple sclerosis.
Must have experienced at least one of the following before the start of the study:
- At least 2 clinical relapses in the last 24 months, but not within 30 days before the study starts. A relapse is a period when symptoms get worse.
- At least 1 clinical relapse in the past 24 months, but not within 30 days before the study starts, and at least 1 new brain MRI lesion in the past 12 months. An MRI lesion is an area of damage in the brain seen on an MRI scan.
- At least 1 Gadolinium-enhancing (GdE) lesion on a brain MRI within 6 months before the study starts. A GdE lesion is a specific type of brain lesion that shows active inflammation.
- Both males and females can participate.

Who cannot join the trial?

10 criteria

Participants cannot join if they have any other serious health conditions that might interfere with the study.
Individuals who are pregnant or breastfeeding are not eligible to participate.
Participants must not have had any recent infections that required treatment with antibiotics or antiviral medications.
People who have had a history of severe allergic reactions to any medications are excluded.
Participants should not have received any other investigational drugs within a certain period before the study.
Individuals with a history of drug or alcohol abuse may not participate.
Participants must not have any significant liver or kidney problems.
People with a history of cancer, except for certain types of skin cancer, are excluded.
Participants should not have any uncontrolled high blood pressure or heart disease.
Individuals who have had a recent vaccination may not be eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD
Verified
Sofia, Bulgaria
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

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Investigated drugs

BIIB091
is a medication being studied for its potential to help people with relapsing forms of multiple sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves. In this trial, researchers are looking at how safe and tolerable BIIB091 is when used by itself. They are also interested in seeing how it works when combined with another medication, compared to using the other medication alone. The goal is to see if BIIB091 can help reduce inflammation in the central nervous system, which is a key problem in multiple sclerosis.
Diroximel Fumarate
is a medication already used to treat relapsing forms of multiple sclerosis. It works by helping to reduce inflammation and protect the nerves from damage. In this trial, Diroximel Fumarate is being used as a comparison to see if adding BIIB091 can improve its effects. Researchers want to find out if the combination of these two medications can better manage the symptoms of multiple sclerosis and reduce the activity of the disease as seen on MRI scans.

What is already known about the treatment

BIIB091 – BIIB091 is an investigational medication currently being studied for its potential use in treating relapsing forms of multiple sclerosis. It is administered orally, meaning it is taken by mouth in the form of a pill. The main focus of current research is to assess its safety and how well it works, both on its own and in combination with another medication called Diroximel Fumarate. BIIB091 is believed to work by targeting specific pathways in the immune system to reduce inflammation in the central nervous system, which is a key factor in multiple sclerosis. It is classified as an immunomodulatory agent, which means it helps to regulate or normalize the immune system's response.

Investigated diseases

Relapsing Forms of Multiple Sclerosis – This is a neurological condition characterized by episodes of new or worsening symptoms, known as relapses, followed by periods of partial or complete recovery. It affects the central nervous system, leading to symptoms such as fatigue, vision problems, and muscle weakness. The disease progresses with the immune system mistakenly attacking the protective covering of nerve fibers, causing communication issues between the brain and the rest of the body. Over time, the disease can lead to permanent damage or deterioration of the nerves. The frequency and severity of relapses can vary greatly among individuals. As the disease progresses, it may lead to more persistent symptoms and disability.