Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open-label long-term extension period

This research study is investigating a new medication called SAR443820 for people living with multiple sclerosis, or MS. It's a 'Phase 2' trial, which means it's still quite early in its development. The main goal is to see if this new drug can reduce the levels of a substance in the blood called neurofilament. High levels of neurofilament can be a sign of nerve damage in conditions like MS. Participants will receive either the new drug or a dummy treatment (placebo) for a period, with some then continuing into an open-label part where everyone gets the active drug. Doctors will also track other changes like disability progression, brain scans, and any side effects to understand how safe and effective the treatment might be for MS.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

157

Start

24 Apr 2024

Multiple sclerosis

What is this study about?

This study is a research project looking into a new medication called SAR443820 for people who have multiple sclerosis (MS). MS is a condition that affects your brain and spinal cord, leading to a range of symptoms. Finding new treatments is really important to help manage the condition and improve quality of life for those affected. This particular study is in an earlier stage, known as Phase 2, where scientists are working to understand if the drug works and what its side effects might be.

The main thing researchers want to find out is if SAR443820 can lower something called 'neurofilament' in your blood. Think of neurofilament as a tiny piece of nerve cell; if a lot of it is found in your blood, it can suggest that nerve cells are being damaged. By seeing if the drug can reduce these levels, doctors hope to understand if it might be helping to protect nerves in people with MS. They will measure these levels after about a year and again after about two years.

Beyond just neurofilament levels, the study will also look at many other aspects. This includes using special brain scans (called MRIs) to check for changes in the brain related to MS, and seeing if the drug affects how MS symptoms change over time, such as your walking or balance. They'll also carefully record any side effects people experience, to make sure the drug is as safe as possible.

Key takeaways

This study is testing a new drug, SAR443820, for multiple sclerosis (MS).
It aims to see if the drug can reduce signs of nerve damage in the blood.
Participants will receive either the drug or a placebo during the main part of the study.
Regular health checks, blood tests, and MRI scans will be part of the process.
The study also monitors MS symptoms and brain changes over time.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

There will be specific health checks and medical history reviews to make sure the study medication is suitable and safe for you. This often includes having a diagnosis of multiple sclerosis and meeting certain criteria related to your overall health and other medications you might be taking.

Before joining, the study team will go through all the detailed requirements with you to confirm if it's the right study for you to consider.

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?
Have you been diagnosed with multiple sclerosis?
Are you able to attend regular clinic appointments?
Are you comfortable with blood tests and MRI scans?
Are you currently in good general health apart from your MS?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first go through a screening period to make sure you meet all the criteria. If you qualify, you would then be randomly assigned to either receive the new study drug, SAR443820, or a placebo (a dummy treatment that looks just like the drug but contains no active medicine). This part of the study is 'double-blind,' meaning neither you nor your study doctor will know which treatment you are receiving. This helps to ensure the results are as fair and unbiased as possible.

Throughout the study, you would have regular visits to the clinic for medical check-ups, blood tests (to measure things like neurofilament levels), and possibly MRI brain scans to monitor your MS. You would also have assessments to see how your symptoms and physical abilities are changing. After a certain period, there might be an 'open-label' extension where all participants receive the active study drug. The study is expected to last for a significant period, potentially around two years for the blinded part and longer for the open-label extension, with follow-up appointments continuing for some time after that.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. A potential benefit of joining this study is that you might receive access to a new treatment for MS that isn't yet widely available, which could potentially help manage your condition. However, there's no guarantee the treatment will work for you, and you might receive the placebo. Possible risks include experiencing side effects from the study medication, discomfort from blood tests or MRI scans, and the time commitment required for clinic visits. Your doctors will carefully monitor you for any side effects or health changes. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without 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
Spain
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Unverified
Belgium
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Unverified
Germany
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Unverified
Italy
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
France

Common questions

What is SAR443820?

SAR443820 is the name of the new medication being tested in this study for people with multiple sclerosis (MS).

What does 'Phase 2' mean?

Phase 2 means it's an earlier stage of testing for a new drug. Researchers are trying to see if it works and what side effects it might have, but it's not yet approved for general use.

What is 'neurofilament'?

Neurofilament is a substance found in nerve cells. High levels in the blood can suggest nerve damage, and researchers want to see if the new drug can lower these levels in MS.

Will I know if I'm getting the real drug or a dummy treatment?

For part of the study, neither you nor your doctor will know if you're getting the active drug or a placebo (dummy treatment). This is called 'double-blind'.

How long will the study last?

The main part of the study will involve treatments and assessments over about two years, with possible continuation into an 'open-label' period where everyone receives the active drug.