Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis

This research is a two-part study for people who have relapsing forms of multiple sclerosis, a condition affecting the brain and spinal cord. It's looking into a new treatment called BIIB091. In the first part, researchers will compare BIIB091 on its own against commonly used steroid treatment, Solu-Moderín, focusing on how safe BIIB091 is and any side effects. The second part will then test BIIB091 alongside existing MS medicine, Vumerity, to see if the combination works better at preventing new signs of MS on brain scans. Importantly, no one in this study will receive a dummy treatment (placebo) instead of an active medicine, ensuring everyone gets potential therapy. The main goal is to understand if BIIB091 is safe and effective for treating MS.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Biogen Idec Research Limited

Enrolment target

225

Start

14 Aug 2023

Relapsing Forms of Multiple Sclerosis

What is this study about?

This study is designed to explore a new potential medication called BIIB091 for people living with relapsing forms of multiple sclerosis (MS). MS is a condition that affects your brain and spinal cord, and 'relapsing' means you experience periods of new symptoms or worsening old ones, followed by recovery or remission.

The research is split into two main parts. In the first part, doctors want to find out how safe the new medication, BIIB091, is when given on its own. They will compare it to a standard treatment for MS flare-ups, which is a steroid medicine called Solu-Moderín. In this part, they'll mainly be looking for any side effects or unwanted reactions. The second part of the study will then investigate if BIIB091 works better when it's given together with a medicine already approved for MS called Vumerity. Here, they will specifically measure if the combination of medicines helps prevent new signs of MS activity in the brain, which they can see on special scans.

It's important to know that this study is designed so that everyone taking part will receive an active medicine. There isn't a group that receives only a placebo (a dummy treatment). This means all participants will be getting medicine that could potentially help with their MS. The overall aim is to gather more information about BIIB091 – both how safe it is and how well it might work, either by itself or with other treatments, to help manage relapsing MS.

Key takeaways

This study is testing a new medicine, BIIB091, for relapsing MS.
It will check BIIB091's safety and effectiveness alone and with Vumerity.
No one in this study will receive a placebo; everyone gets active treatment.
Participants will have regular check-ups, blood tests, and MRI scans.
The study aims to improve treatments for relapsing MS.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older, and have a confirmed diagnosis of relapsing forms of multiple sclerosis. This means you experience episodes where your MS symptoms get worse or new symptoms appear, followed by periods of improvement.

Beyond your age and MS type, there are other specific medical requirements that your doctor would need to check. These might include your general health, other medications you're taking, or results from past medical tests. These details are important to make sure the study medication is suitable and safe for you, and that the study results are clear.

Your MS doctor or specialist will be able to review all these criteria with you to determine if you are a good fit for this particular research study. They will also make sure you understand what's involved before you decide to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of relapsing forms of multiple sclerosis?
Are you able to attend regular clinic appointments for tests and check-ups?
Are you willing to potentially receive either a new experimental drug or a standard treatment?
Are you currently not pregnant or planning to become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine BIIB091 on its own, or BIIB091 combined with Vumerity, another existing MS medicine. In the first part of the study, some people will receive a steroid medicine called Solu-Moderín for comparison. You won't receive a dummy treatment (placebo) by itself. The study involves regular visits to the clinic where you'll have various check-ups, including physical examinations, blood tests, and special brain scans called MRI scans to monitor your MS.

The researchers will closely watch for any side effects or changes in your health throughout the study. You will also have heart tests, like ECGs, to make sure the medicines aren't affecting your heart. The exact number of visits and the full duration of your participation will be explained by the study team, as it varies between the two parts of the study and depending on how you respond to treatment. You will receive all study medications and assessments at no cost.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that you might have access to a new treatment, BIIB091, which could help manage your relapsing MS. However, as BIIB091 is a new medicine, there might be unknown side effects or it might not work as expected. The study team will closely monitor you for any side effects and overall changes in your health. You will also receive regular medical care and assessments as part of the study. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Czechia
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Unverified
Spain
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Unverified
Italy
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Unverified
Poland
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Unverified
Bulgaria
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Unverified
Romania

Common questions

What is multiple sclerosis (MS)?

MS is a condition that affects your brain and spinal cord, which are parts of your central nervous system. It can cause a wide range of symptoms like tiredness, problems with walking, vision issues, and numbness.

What are 'relapsing forms' of MS?

This means you experience periods where your MS symptoms get worse or new symptoms appear (called a relapse or flare-up), followed by periods where your symptoms get better or stable (remission).

Will I receive a placebo in this study?

No, you will not. All participants in this study will receive active medication; no one will be given only a dummy treatment (placebo).

What is BIIB091?

BIIB091 is the new medication being investigated in this study. Researchers are trying to find out if it's safe and effective for treating relapsing forms of MS.

Will I have brain scans during the study?

Yes, you will have regular MRI scans (special brain scans) to help the doctors see if the treatment is affecting your MS.