Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
This clinical trial is investigating a new medication called frexalimab for adults aged 18 to 60 living with non-relapsing secondary progressive multiple sclerosis (nrSPMS). The main goal is to find out if frexalimab can effectively slow down the worsening of MS symptoms and disabilities over time, and to assess its safety. Participants will be randomly assigned to receive either frexalimab or a placebo (a dummy drug without active ingredients). This is a 'double-blind' study, meaning neither the participants nor their doctors will know who is receiving the actual drug. The study is expected to last around 43 months, with regular check-ups to monitor health and MS progression.
At a glance
What is this study about?
This research study is focused on a type of multiple sclerosis (MS) called non-relapsing secondary progressive MS (nrSPMS). In this form of MS, symptoms gradually get worse over time without clear periods of improvement or sudden attacks (relapses). The new drug being tested is called frexalimab. Researchers want to understand if frexalimab can help to slow down this gradual worsening of MS and improve the quality of life for people living with nrSPMS. They also want to make sure the drug is safe for people to use.
To do this, around 180 people with nrSPMS will be involved in the study. Some will receive frexalimab, and others will receive a placebo – which looks exactly like the study drug but contains no active medicine. This is a common way to test new treatments, as it helps researchers see if the effects are truly due to the drug itself rather than other factors. Neither you nor your study doctor will know whether you are receiving frexalimab or the placebo, which helps keep the results unbiased.
The study aims to discover if frexalimab can delay the progression of disability that often occurs with nrSPMS. This is a 'Phase 3' trial, which means it’s one of the final stages of testing before a new medicine might be considered for wider use. By participating, you could help scientists learn more about nrSPPS and potentially contribute to developing new treatments for this challenging condition.
Key takeaways
- This study is testing a new drug, frexalimab, for non-relapsing secondary progressive MS (nrSPMS).
- Its main goal is to see if frexalimab can slow down MS progression and is safe.
- Participants will receive either frexalimab or a placebo (dummy drug).
- The study is expected to last for about 43 months with regular clinic visits.
- You must be 18-60 years old and meet specific MS diagnosis criteria.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would need to have been diagnosed with relapsing-remitting MS (RRMS) in the past, and currently have a diagnosis of secondary progressive MS (SPMS). Importantly, your MS must be 'non-relapsing', meaning you haven't experienced any new MS attacks (relapses) for at least two years before the study starts. Your disability level, measured by a common MS scale, should be between 3.0 and 6.5.
There are also some specific medical conditions that would prevent you from taking part. For example, if you have a history of serious infections, problems with your immune system, or certain heart or blood clot conditions, you might not be eligible. If you've previously been offered a drug called siponimod for your MS but either couldn't tolerate it, found it wasn't working, or chose not to take it, you might still be able to join this study.
The study is open to both men and women between the ages of 18 and 60. You would also need to agree to use effective contraception throughout the study, if applicable. A committee of experts will review your medical information to ensure you meet all the necessary requirements.
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.
- Have you been diagnosed with relapsing-remitting MS (RRMS) in the past?
- Do you currently have secondary progressive MS (SPMS) with no relapses for at least 2 years?
- Are you between 18 and 60 years old?
- Do you have a disability score (EDSS) between 3.0 and 6.5?
- Do you have no history of serious infections or certain heart/blood clotting problems?
- Are you willing to use effective contraception if needed during the study?
What does participation involve?
If you decide to take part in this study, it's expected to last for about 43 months, which is just over 3 and a half years. You will have regular visits to the study clinic – monthly for the first six months, and then every three months afterwards. In total, there could be up to 25 scheduled visits, including some follow-up appointments after your main treatment period. During these visits, the study team will monitor your health, check your MS symptoms, and carry out various assessments. You might also have MRI scans to look at changes in your brain, and blood tests will be taken regularly. The study medication or placebo will be given to you during these visits. The study will continue until a certain number of people experience a confirmed worsening of their MS over a 6-month period, which is a key measure of how well the treatment is working.
Potential risks and benefits
Locations (311)
- Alabama Neurology Associates- Site Number : 8400115Verified postcodeHomewood, United States
- Perseverance Research Center- Site Number : 8400138Verified postcodeScottsdale, United States
- Imaging Endpoints- Site Number : 8400050Verified postcodeScottsdale, United States
- Sutter East Bay Medical Foundation - Berkeley- Site Number : 8400134Verified postcodeBerkeley, United States
- University of California Irvine - School of Medicine- Site Number : 8400143Verified postcodeIrvine, United States
- University of California San Diego - La Jolla- Site Number : 8400095Verified postcodeLa Jolla, United States
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400184Verified postcodeLos Angeles, United States
- Hoag Memorial Hospital Presbyterian- Site Number : 8400031Verified postcodeNewport Beach, United States
- Stanford Neuroscience Health Center- Site Number : 8400120Verified postcodePalo Alto, United States
- Private Practice - Dr. Regina Berkovich- Site Number : 8400005Verified postcodeWest Hollywood, United States
- University of Colorado - Anschutz Medical Campus- Site Number : 8400001Verified postcodeAurora, United States
- Advanced Neurology of Colorado- Site Number : 8400148Verified postcodeFort Collins, United States
Common questions
What is non-relapsing secondary progressive MS (nrSPMS)?
It's a type of MS where your symptoms gradually worsen over time without distinct attacks or periods of improvement.
What is frexalimab?
Frexalimab is the name of the new investigational drug being tested in this study for nrSPMS.
What does 'double-blind, placebo-controlled' mean?
It means neither you nor your doctor will know if you're getting the active drug or a dummy drug (placebo), which helps ensure fair and accurate results.
How long will the study last?
The study is expected to last for about 43 months, which is just over 3 and a half years.
Can I leave the study at any time?
Yes, your participation is voluntary, and you can withdraw from the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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