Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

This research study is testing a new drug called remibrutinib for adults with relapsing multiple sclerosis (RMS). It aims to find out if remibrutinib is more effective and safer than a current treatment, teriflunomide. Participants will be taking one of these two medicines. The study is split into two parts: a main part lasting up to 30 months where people are given either remibrutinib or teriflunomide without knowing which, and a longer part where all eligible participants will receive remibrutinib for up to five years. About 800 people will take part globally. The information gathered will help doctors understand if remibrutinib could be a useful new option for people living with RMS.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

1,007

Start

13 Dec 2021

Estimated completion

30 Oct 2030

Relapsing Multiple Sclerosis

What is this study about?

This study is designed to learn more about a new medication called remibrutinib for people who have relapsing multiple sclerosis, often shortened to RMS. RMS is a condition where the body's immune system mistakenly attacks the protective covering of nerves, leading to symptoms that come and go. Scientists are comparing remibrutinib with teriflunomide, an existing treatment for MS, to see if the new medicine works better or has fewer side effects. This kind of research is really important because it helps develop new and improved treatments for people living with MS.

The study involves around 800 people across the world. It's divided into two main stages. In the first stage, participants will be randomly assigned to receive either remibrutinib or teriflunomide, but neither they nor their doctors will know which one they are taking. This helps ensure fair results. This part can last up to two and a half years. After this, if certain conditions are met, participants can enter a second, longer stage where they will all receive remibrutinib for up to five years. This extended part helps researchers understand the long-term effects of remibrutinib.

The aim is to collect lots of information on how both medications affect MS symptoms, how safe they are, and if people experience any side effects. By carefully comparing these two treatments, researchers hope to show whether remibrutinib could be a valuable addition to the treatments available for people with relapsing multiple sclerosis. This could potentially offer new hope and options for managing the condition.

Key takeaways

This study is testing a new drug for relapsing MS called remibrutinib.
It compares remibrutinib to an existing MS treatment, teriflunomide.
The study involves up to 800 people and has a main part (up to 2.5 years) and an extension part (up to 5 years).
Participation means regular visits and close monitoring of your health.
You have the right to leave the study at any time if you change your mind.
This research aims to find new and better treatments for relapsing MS.

Who may be eligible?

To join this study, you generally need to be between 18 and 55 years old and have been diagnosed with relapsing multiple sclerosis (RMS) fairly recently, specifically according to guidelines from 2017. You should have experienced at least one MS relapse in the last year, or two in the last two years, or have shown signs of active MS on a brain scan in the last year. Your MS symptoms should also be fairly stable and not too severe.

There are also reasons why you might not be able to join. For example, if you have a different type of MS called primary progressive multiple sclerosis (PPMS), or if you've had MS for a very long time with milder symptoms. You also can't participate if you have other serious health conditions like certain cancers, severe infections, active uncontrolled diseases (like asthma), or problems with your heart, lungs, or kidneys that could affect the study results. People with a history of certain serious brain infections or immune system problems are also not able to join.

Basically, the research team wants to ensure that people joining the study are a good fit and that the results will be clear and helpful for others with RMS, while also keeping participants safe.

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 relapsing multiple sclerosis (RMS)?
Have you had at least one MS relapse in the last year, or active MS signs on a recent scan?
Is your MS fairly stable, not getting rapidly worse right now?
Do you generally have good overall health, without other serious medical conditions?
Do you understand that you can't have certain other serious conditions to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first go through a screening process to make sure you meet all the requirements. If you qualify, you'll be randomly assigned to receive either remibrutinib or teriflunomide. You won't know which one you're taking, and neither will your doctor for the first part of the study. You'll take the medicine as prescribed and attend regular clinic visits where the study team will monitor your health, perform tests, and ask about your symptoms and any side effects. This main part of the study could last up to two and a half years.

After this initial stage, if you meet certain criteria and wish to continue, you could enter an 'extension part' of the study. In this part, all eligible participants will receive remibrutinib, and it could last for up to five years. Throughout both parts, you'll have appointments to check on your progress and ensure your safety. The total duration of your involvement could be several years.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment (remibrutinib) before it's widely available, or receiving an established MS medication (teriflunomide) with close medical monitoring. You'll also be contributing to important scientific research that could help others with MS in the future. However, there are also potential risks; you might experience side effects from either medication that are not yet fully known, or the treatment might not be effective for you. There's also the time commitment involved with clinic visits and tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (223)

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

Ctr for Neurology and Spine
Verified postcode
Phoenix, United States
Vladimir Royter MD APMC
Verified postcode
Hanford, United States
VA Greater LA Healthcare System
Verified postcode
Los Angeles, United States
Regina Berkovich MD PhD Inc
Verified postcode
West Hollywood, United States
CU Anschutz Med Campus
Verified postcode
Aurora, United States
Colorado Neurological Research PC
Verified postcode
Denver, United States
New England Institute for Clinical Research
Verified postcode
Stamford, United States
Georgetown University Hospital Research
Verified postcode
Washington D.C., United States
Georgetown University Hospital
Verified postcode
Washington D.C., United States
Nova Clinical Research LLC
Verified postcode
Bradenton, United States
University of Florida
Verified postcode
Gainesville, United States
Memorial Healthcare System
Verified postcode
Hollywood, United States

Common questions

What is 'relapsing multiple sclerosis'?

Relapsing multiple sclerosis (RMS) is a type of MS where symptoms come in 'attacks' or 'relapses', followed by periods of recovery. The study is specifically for people with this form of MS.

Who is funding this study?

The information provided indicates this is a clinical trial, typically funded by the pharmaceutical company developing the new drug, in this case, likely the company behind remibrutinib.

Will I know if I'm getting the new drug or the existing one?

For the first part of the study, you won't know if you're receiving remibrutinib or teriflunomide, and neither will your doctor. This is done to ensure the study is fair.

How long will I have to be in the study?

The first part of the study lasts up to 30 months (two and a half years). If you are eligible and choose to continue, there's an optional longer part where you could receive treatment for up to five additional years.

What does a 'Phase 3' study mean?

Phase 3 means this is a large study comparing the new drug to an existing treatment or a placebo in many people, to confirm its effectiveness and safety before it can be approved for wider use.