All studies
RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

This research study is testing a new medication, remibrutinib, for people living with Secondary Progressive Multiple Sclerosis (SPMS). The main goal is to find out if remibrutinib is effective in treating SPMS and if it’s safe to use. Some participants will receive remibrutinib, while others will get a placebo (a dummy drug with no active medicine) at first. Later, all participants will have the chance to receive remibrutinib. This is a large study involving many people and medical centres. By taking part, you could help doctors learn more about SPMS and how to treat it, potentially improving care for many people in the future.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Novartis Pharmaceuticals
Enrolment target
1,275
Start
11 Nov 2025
Estimated completion
02 Jan 2034

What is this study about?

This research study is about finding new ways to help people with Secondary Progressive Multiple Sclerosis (SPMS). SPMS is a form of MS where symptoms gradually get worse over time, without clear periods of improvement. Currently, there aren't many treatments for SPMS, so finding new options is really important.

The study is testing a medication called remibrutinib. The main purpose is to see if remibrutinib can effectively slow down or stop the progression of SPMS and to make sure it's safe for people to take. Researchers will compare remibrutinib to a 'placebo' – which looks like the real medicine but contains no active drug. This helps them understand if any changes seen are truly due to the study medicine or something else.

After an initial period where some people get the active medicine and some get the placebo (without knowing which they are receiving), all participants will then have the opportunity to take remibrutinib. This study is a crucial step in potentially bringing a new treatment option to people living with SPMS.

Key takeaways

  • This study is testing a new drug, remibrutinib, for Secondary Progressive MS (SPMS).
  • It aims to see if the drug is both safe and effective.
  • Some participants will initially receive a placebo (dummy drug).
  • All participants will eventually have access to the new drug.
  • Regular checks, including MRI scans, will be part of the study.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people must be between 18 and 65 years old and have a confirmed diagnosis of Secondary Progressive Multiple Sclerosis (SPMS). It's important that you haven't had any new MS attacks or relapses in the last two years, and your disability has shown some progression in the past year.

There are also reasons why someone might not be able to join. For example, if you can't have an MRI scan because of certain medical conditions (like some metal implants) or if you have other serious health issues that might interfere with the study. If you are a woman who could become pregnant, you would need to use effective birth control throughout the study. Heavy drinking or drug use, or other serious mental health conditions, would also prevent you from taking 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.

  1. Are you between 18 and 65 years old?
  2. Do you have a diagnosis of Secondary Progressive MS (SPMS)?
  3. Have you not had an MS relapse in the last two years?
  4. Has your disability shown a steady increase in the last year?
  5. Are you able to have MRI scans?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you're suitable. Once you're in, you'll be randomly assigned to either receive remibrutinib or a placebo (a dummy drug) for the first part of the study. Neither you nor the study team will know which one you are getting. After this initial 'blinded' period, everyone will then get the chance to receive remibrutinib openly.

Throughout the study, you'll have regular hospital or clinic visits. During these visits, you'll likely have physical exams, blood tests, and MRI scans to monitor your health and see how the medication is affecting your MS. The doctors will also ask you questions about your symptoms and how you're feeling. The study is designed to continue until a certain number of progression events have occurred in the study group, which means the total duration could vary and will be explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new medication that could help manage your SPMS, or you might gain a better understanding of your condition through regular monitoring. However, there's always a risk of side effects from the medication, even with a placebo, and the study procedures (like blood tests or MRI scans) can be time-consuming or uncomfortable. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (208)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alabama Neurology Associates PC
    Verified postcode
    Birmingham, United States· Recruiting
  • AZ Integrated Neuro and Spine
    Verified postcode
    Phoenix, United States· Recruiting
  • Center for Neurosciences
    Verified postcode
    Tucson, United States· Recruiting
  • Fullerton Neuro and Headache Ctr
    Verified postcode
    Fullerton, United States· Recruiting
  • Regina Berkovich MD PhD Inc
    Verified postcode
    West Hollywood, United States· Recruiting
  • Georgetown University Hospital
    Verified postcode
    Washington D.C., United States· Recruiting
  • Medstar Washington Hosp Ctr
    Verified postcode
    Washington D.C., United States· Recruiting
  • Neurology of Central FL Res Ctr
    Verified postcode
    Altamonte Springs, United States· Recruiting
  • UF Health Cancer Center
    Verified postcode
    Gainesville, United States· Recruiting
  • Homestead Assoc In Research Inc
    Verified postcode
    Homestead, United States· Recruiting
  • Neurology Associates PA
    Verified postcode
    Maitland, United States· Recruiting
  • Miami NS Ins Baptist Health S FL
    Verified postcode
    Miami, United States· Recruiting

Common questions

What is Secondary Progressive Multiple Sclerosis (SPMS)?

SPMS is a type of MS where symptoms gradually worsen over time, without clear periods of improvement.

What is remibrutinib?

Remibrutinib is an investigational medication being tested in this study to see if it can help people with SPMS.

What is a 'placebo'?

A placebo is a dummy drug that looks like the real medicine but contains no active ingredients. It's used to compare against the active medicine to see if it truly works.

Will I know if I'm getting the study drug or the placebo?

For the first part of the study, neither you nor the doctors will know. This is called 'double-blinded'. Later, everyone will have the chance to receive remibrutinib openly.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Novartis Pharmaceuticals

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Efficacy and Safety of Remibrutinib …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.