RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

This research study is for people aged 40 to 70 in the UK who have relapsing multiple sclerosis (RMS) and are currently taking ocrelizumab. The main goal is to find out if a new oral medicine called remibrutinib is effective and safe when people switch from ocrelizumab. Researchers will compare how well remibrutinib works against continuing to take ocrelizumab. This is a Phase 3 study, meaning it's a later stage of research designed to confirm the medicine's benefits and safety in a larger group of patients. The study aims to provide important information for treating RMS, helping to understand if remibrutinib could be another helpful option.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

360

Start

23 Jul 2025

Estimated completion

24 Jun 2031

Relapsing Multiple Sclerosis

What is this study about?

This study is looking into a new medicine called remibrutinib for people living with a type of multiple sclerosis (MS) called relapsing multiple sclerosis (RMS). RMS means you have periods where your symptoms get worse (relapses), followed by periods of recovery. Currently, you might be taking a medicine called ocrelizumab to help manage your MS.

The main aim of this study is to see if switching from ocrelizumab to remibrutinib, which you take by mouth, is as good as, or even better than, staying on ocrelizumab. Researchers will also be checking how safe remibrutinib is and if people can tolerate it well. This is a 'Phase 3b' study, which means it’s a later-stage trial where doctors are confirming how effective and safe a new treatment is in a larger group of people.

Participants will be split into groups; some will switch to remibrutinib, while others will continue their ocrelizumab treatment. The study will last for up to 24 months in its first part, with an option to continue for another 24 months on remibrutinib if you’re suitable. Your doctors will keep a close eye on your health and MS symptoms throughout the study.

Key takeaways

This study compares a new oral medicine (remibrutinib) with an existing one (ocrelizumab) for relapsing MS.
It’s for people aged 40-70 who are already taking ocrelizumab.
The study will check if switching to remibrutinib is safe and effective.
Participation involves regular clinic visits, blood tests, and MRI scans.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

To join this study, you generally need to be a man or woman aged between 40 and 70 years old (inclusive), who has been diagnosed with relapsing multiple sclerosis (RMS) using the 2017 McDonald criteria. You should also already be receiving ocrelizumab treatment as part of your usual care and be stable, meaning your condition hasn't changed much in the last 30 days.

On the other hand, you wouldn't be able to join if you have a different type of MS called primary progressive multiple sclerosis (PPMS). You also can't take part if you've had certain serious medical conditions, such as significant infections, severe heart problems, or other immune system diseases. If you've had a severe reaction to ocrelizumab in the past, or can't have MRI scans, you also wouldn't be able to join. Your doctor will make the final decision based on all your health information.

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 40 and 70 years old?
Do you have a diagnosis of relapsing multiple sclerosis (RMS)?
Are you currently taking the medicine ocrelizumab?
Have you been generally stable with your MS symptoms in the last month?
Do you *not* have other serious medical conditions like severe heart problems or active infections?

Answer every question to see your result.

What does participation involve?

Taking part in this study involves regular visits to the clinic for assessments. These will include check-ups by doctors and nurses, blood tests, and MRI scans to monitor your multiple sclerosis. If you are in the group that switches to remibrutinib, you will take this medicine by mouth. If you are in the continuous ocrelizumab group, you will receive your usual ocrelizumab treatment. The first part of the study lasts up to 24 months, and if you are suitable and wish to, you could continue in an extension part for another 24 months, where everyone would receive remibrutinib. Throughout the study, your health will be carefully monitored.

Potential risks and benefits

Participating in a study means you might receive a new treatment that could potentially help manage your MS. However, like all medicines, remibrutinib could have side effects, and it's possible it may not work for everyone. There’s also the chance that the treatment you receive might not be as effective as your current one. All potential risks will be thoroughly explained to you, and your health will be closely supervised. Remember, joining is entirely voluntary, and you can change your mind and withdraw from the study at any time without it affecting your usual medical care.

Locations (106)

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

Perseverance Research Center
Verified postcode
Scottsdale, United States· Recruiting
University of California Irvine
Verified postcode
Irvine, United States· Recruiting
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States· Recruiting
Neurology of Central FL Res Ctr
Verified postcode
Altamonte Springs, United States· Recruiting
University of Florida
Verified postcode
Gainesville, United States· Recruiting
Neurology Associates PA
Verified postcode
Maitland, United States· Recruiting
Aqualane Clinical Research
Verified postcode
Naples, United States· Recruiting
Advent Health Orlando
Verified postcode
Orlando, United States· Recruiting
Orlando Health Clinical Trials
Verified postcode
Orlando, United States· Recruiting
Tallahassee Neurological Clinic
Verified postcode
Tallahassee, United States· Recruiting
University Of South Florida
Verified postcode
Tampa, United States· Recruiting
Vero Beach Neurology
Verified postcode
Vero Beach, United States· Recruiting

Common questions

What is relapsing multiple sclerosis (RMS)?

RMS is a type of MS where you have periods of new or worsening symptoms (relapses) followed by periods of recovery.

What is remibrutinib?

Remibrutinib is a new medicine being tested in this study. It's a tablet you take by mouth.

What is ocrelizumab?

Ocrelizumab is an existing medicine used to treat relapsing multiple sclerosis, which is given by infusion.

How long will the study last?

The main part of the study lasts up to 24 months, with an option for suitable participants to continue for another 24 months.

Do I have to stop my current MS treatment to join?

If you are on ocrelizumab, some participants will switch to the new medicine, while others will continue with ocrelizumab. The study setup will determine which group you are in.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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