Active not recruitingPHASE3INTERVENTIONAL

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

This research is looking at a new treatment called remibrutinib for people with relapsing multiple sclerosis (RMS). It will compare remibrutinib against an established medication, teriflunomide, which is already used to treat RMS. The main goals are to find out if remibrutinib is effective at controlling RMS relapses and if it has any side effects. This is a large study that will involve around 800 participants and will last for several years. It's designed to give us a clear picture of how remibrutinib performs in a real-world setting, hopefully offering another option for people living with RMS.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

1,000

Start

16 Dec 2021

Estimated completion

30 Oct 2030

Relapsing Multiple Sclerosis

What is this study about?

This study is investigating a new treatment called remibrutinib for people living with a type of multiple sclerosis known as relapsing multiple sclerosis (RMS). RMS is characterised by periods of new or worsening symptoms (relapses) followed by periods of recovery. The main goal of this research is to see how effectively remibrutinib can prevent these relapses and to understand its safety profile – meaning, what side effects it might have. This is a 'Phase 3' study, which means it's a large-scale investigation that is usually one of the final steps before a new medicine can be considered for wider use.

To get a clear understanding, the study will compare remibrutinib directly with an existing treatment for RMS called teriflunomide. Participants will be randomly assigned to receive either the new drug or the existing one. Neither the participants nor their doctors will know which treatment they are receiving, which helps ensure the results are as fair and unbiased as possible. The study will carefully monitor participants over several years to track their relapses and any side effects.

There are actually two identical studies happening at the same time around the world. Combining the information from both studies will give researchers a very robust and reliable picture of how remibrutinib works. The findings from this research could ultimately lead to a new treatment option for people with relapsing multiple sclerosis, offering more choices in managing this condition.

Key takeaways

This study is testing a new MS drug (remibrutinib) against an existing one (teriflunomide).
It's for people aged 18-55 with relapsing multiple sclerosis (RMS).
Participation involves regular clinic visits and lasts for several years.
The study aims to check the new drug's effectiveness and safety.
Two identical studies are running globally to gather robust data.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 55 years old and have a confirmed diagnosis of relapsing multiple sclerosis (RMS). Your MS diagnosis should meet specific criteria, and you would need to have experienced a certain number of relapses recently, or show signs of active disease on an MRI scan. Your level of disability from MS, as measured by a specific scale, would also need to fall within a certain range.

There are also some reasons why you might not be able to join. For example, if you have a different type of MS (like primary progressive MS), or have certain other significant medical conditions affecting your heart, lungs, kidneys, or immune system. You would also not be eligible if you have a history of certain cancers or serious infections, or if you've recently had a spleen removal. The study needs participants to be generally stable and without other serious health issues that could interfere with the study results or your safety.

Quick self-check

Are you between 18 and 55 years old?
Do you have a diagnosis of relapsing multiple sclerosis (RMS)?
Have you had recent MS relapses or active disease on an MRI?
Do you generally not have other serious medical conditions?
Have you not had a spleen removal?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the initial phase would last up to 30 months, which is about two and a half years. During this time, you would be randomly assigned to receive either remibrutinib or teriflunomide, but neither you nor your doctor would know which one you are getting. You would have regular visits to the clinic for assessments, including check-ups, blood tests, and possibly MRI scans, to monitor your health and how well the treatment is working. After this initial phase, if you meet certain criteria, you might have the option to continue in an 'Extension Part' for up to an additional five years. In this longer part, you would receive remibrutinib, and it would be an 'open-label' study, meaning you and your doctors would know you are receiving remibrutinib. The total duration of your participation could, therefore, be several years depending on your eligibility for the extension.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new and potentially effective treatment for your condition, or receiving careful medical attention and monitoring throughout the study. However, there are also potential risks, including the possibility of experiencing side effects from the study medication, which may be unknown or different from existing treatments. There's also no guarantee that the treatment will be effective for you. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (199)

AZ Integrated Neuro and Spine
Phoenix, United States
Center for Neurosciences
Tucson, United States
The Belinga Clinic
Fort Smith, United States
The Research and Education Inst of Alta Bates Summit Med Grp
Berkeley, United States
The Neuron Clinic
Chula Vista, United States
Glendale Adventist Medical Center
Glendale, United States
Hoag Health System
Newport Beach, United States
SC3 Research Pasadena
Pasadena, United States
Neuro Center
Pomona, United States
Alpine Clinical Research Center
Boulder, United States
Christiana Care Health Services
Newark, United States
Washington Hospital Center
Washington D.C., United States

+187 more sites — see the official record for the full list.

Common questions

What is relapsing multiple sclerosis (RMS)?

RMS is a form of MS where you experience periods of new or worsening symptoms, called relapses, followed by periods of recovery.

What are remibrutinib and teriflunomide?

Remibrutinib is a new medication being tested. Teriflunomide is an existing medication already used to treat RMS.

How long will the study last?

The main part of the study lasts up to 30 months (about 2.5 years), with the possibility of extending for up to another 5 years for eligible participants.

Will I know which medication I'm taking?

In the main study, neither you nor your doctor will know which medication you're receiving. In the extended part, you'll know you're taking remibrutinib.

Can I leave the study at any time?

Yes, your participation is voluntary, and you can withdraw from the study at any point without affecting your medical care.