Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

This research is investigating a new medication called frexalimab for adults aged 18 to 55 who have relapsing forms of Multiple Sclerosis (MS). The main goal is to find out if frexalimab can reduce the number of MS relapses experienced by patients each year, compared to a commonly used MS medicine called teriflunomide. Researchers also want to understand if frexalimab is safe to use. You might be suitable for this study if you have been diagnosed with relapsing MS, have experienced recent relapses or changes seen on an MRI scan, and meet specific health criteria. The study involves regular check-ups, potentially including MRI scans, and will last for at least 12 months for every participant, with some people taking part for longer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

1,655

Start

13 Dec 2023

Estimated completion

06 May 2027

Multiple Sclerosis

What is this study about?

This study is testing a new medicine called frexalimab for people with a type of Multiple Sclerosis (MS) where symptoms come and go, known as `relapsing forms of MS`. MS is a condition that affects your brain and spinal cord, which can lead to a range of symptoms. Researchers want to see if frexalimab can help reduce the number of times people have relapses – sudden worsenings of their MS symptoms – each year. They will compare frexalimab to an existing MS medicine called teriflunomide, which is already used to treat MS.

The study also aims to understand any side effects or risks linked to frexalimab, to make sure it's safe for patients. Finding new and better treatments for MS is very important to help people manage their condition and improve their quality of life. This kind of research helps doctors make informed decisions about the best ways to care for people with MS in the future.

It's important to remember that participating in a clinical trial means you might receive the new study medicine, or you might receive the existing medicine (teriflunomide). Some participants might also receive a `placebo`, which looks like the active medicine but doesn't contain any active ingredients. This helps researchers understand the true effects of the medications.

Key takeaways

Exploring a new MS treatment called frexalimab.
Compares frexalimab to an existing MS medicine, teriflunomide.
Aims to reduce MS relapses and assess safety.
For adults aged 18-55 with active relapsing MS.
Involves regular clinic visits and MRI scans.
Participation lasts at least 12 months, some longer.

Who may be eligible?

To join this study, you need to be an adult between 18 and 55 years old and have been diagnosed with a relapsing form of MS. Your MS should also be active, meaning you've had at least one relapse in the past year, two relapses in the past two years, or a recent change showing on an MRI scan. Your MS symptoms shouldn't be too severe, meaning your disability score (called EDSS) should be 5.5 or less.

There are also some reasons why you might not be able to join. For example, if you have a different type of MS called Primary Progressive MS, or if you've had a recent MS relapse in the last 30 days. You also can't participate if you have certain other health conditions, a history of serious infections, or specific issues that would make it unsafe for you to have an MRI scan, like having a pacemaker or severe claustrophobia.

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 between 18 and 55 years old?
Do you have a diagnosis of relapsing MS?
Have you had an MS relapse or changes on an MRI in the last one to two years?
Do you not have Primary Progressive MS?
Are you able to have an MRI scan?
Do you not have other serious health problems that might exclude you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve regular check-ups. For the first six months, you'll have a visit every four weeks, and then every three months after that. These visits will likely include various assessments to monitor your health and MS. You will also have MRI scans, which may involve having a special dye injected to help show active MS areas.

You'll either be given the new study medicine (frexalimab) or an existing MS medicine (teriflunomide). Some participants may also receive a 'pretend' medicine (placebo) given as an infusion or tablet, to help researchers understand the true effects of the active medicines. The length of time you participate will vary, but everyone will be in the study for at least 12 months. Some people might be in the study for much longer, possibly up to 40 months. After your main treatment period, there will be a final check-up and three follow-up visits.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of trying a new medicine for MS that might help reduce your relapses. However, as with any medication, there are potential risks, including side effects from the study medicines or discomfort from blood tests and MRI scans. Researchers will carefully monitor your health throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (382)

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

University of Alabama at Birmingham- Site Number : 8401135
Verified postcode
Birmingham, United States
North Central Neurology Associates- Site Number : 8401100
Verified postcode
Cullman, United States
Alabama Neurology Associates- Site Number : 8400115
Verified postcode
Homewood, United States
St. Joseph's Hospital and Medical Center- Site Number : 8401139
Verified postcode
Phoenix, United States
Perseverance Research Center- Site Number : 8401138
Verified postcode
Scottsdale, United States
Clinical Endpoints- Site Number : 8400050
Verified postcode
Scottsdale, United States
The Neurology Center of Southern California - Carlsbad- Site Number : 8400023
Verified postcode
Carlsbad, United States
University of California Irvine - School of Medicine- Site Number : 8401143
Verified postcode
Irvine, United States
Multiple Sclerosis Center of California - Laguna Hills- Site Number : 8401122
Verified postcode
Laguna Hills, United States
Chemidox Clinical Trials- Site Number : 8401157
Verified postcode
Lancaster, United States
Hoag Memorial Hospital Presbyterian- Site Number : 8401031
Verified postcode
Newport Beach, United States
Private Practice - Dr. Regina Berkovich- Site Number : 8400005
Verified postcode
West Hollywood, United States

Common questions

What is frexalimab?

Frexalimab is a new medicine being tested to see if it can help people with relapsing forms of Multiple Sclerosis by reducing relapses.

Who can join this study?

Adults aged 18 to 55 with active relapsing MS, who meet specific health criteria, may be eligible.

How long will the study last?

Everyone in the study will participate for at least 12 months, and some individuals may take part for up to 40 months.

Will I know if I'm getting the new medicine or the old one?

This is a `blinded` study, which means neither you nor your study doctor will know which treatment you are receiving until the study is over.

What does 'relapsing forms of MS' mean?

This refers to MS where you have periods of new or worsening symptoms (relapses) followed by periods of recovery.