At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Remibrutinib oral treatment (drug), Ocrelizumab (drug)
- How long the study runs
- Study runs about 72 months (dates as stated)
- About the drug or intervention
- Remibrutinib oral treatment — drug: Remibrutinib tablet taken daily · Ocrelizumab — drug: Ocrelizumab 600mg infusion or 920mg injection
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Novartis Pharmaceuticals, looks at how well people with relapsing multiple sclerosis (a condition where the immune system attacks the nerves) cope when they switch from the medicine ocrelizumab to a medicine called remibrutinib. It checks both how well remibrutinib works and how safe it is. Not stated — ask the trial team about how many people are taking part or where the trial is happening.
Who can take part
- Men or women aged 40 to 70
- A diagnosis of relapsing multiple sclerosis using the 2017 McDonald criteria
- Already treated with ocrelizumab at the standard dose, as in normal care
- Neurologically stable within the last 30 days
- Able to switch to remibrutinib, based on the doctor's judgement or the person's own choice
Who may not be able to
- A diagnosis of primary progressive multiple sclerosis (PPMS)
- Past serious disease of the brain or nervous system, other than multiple sclerosis
- Past confirmed progressive multifocal leukoencephalopathy (a rare brain infection) or symptoms that suggest it
- Active serious infections caused by bacteria, viruses, parasites or fungi
- Another active long-term disease of the immune system besides multiple sclerosis
- Severe heart disease or significant findings on a heart tracing (ECG)
- Unable to have MRI scans
- A past life-threatening reaction to an infusion or injection of ocrelizumab
What taking part involves
- • Switching from ocrelizumab to remibrutinib
- • Taking remibrutinib so researchers can check how well it works and how safe it is
Time commitment: Not stated — ask the trial team about the number of visits, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 40 Years to 70 Years
- Who
- All
- Number of participants
- 400
- Started
- 2025-06-23
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for relapsing multiple sclerosis
- • Phase3 - 400 participants
- • The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS)
Who can take part?
- • Ages 40 Years to 70 Years
- • Diagnosed with relapsing multiple sclerosis
Where?
- • Sheffield - Novartis Investigative Site
- • Leeds - Novartis Investigative Site
- • London - Novartis Investigative Site
- • Swansea - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
More detail
The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS. This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants. All participants completing the 24-month treatment of the Core Part of the study may be eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months. The study will be conducted in the USA among other countries globally.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Male or female aged 40 to 70 years (inclusive)
- ✓Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
- ✓Treated with ocrelizumab according to routine clinical practice and at standard dose
- ✓Neurologically stable within 30 days
- ✓Suitable to be switched to remibrutinib based on physician judgement or patient preference
Who cannot take part
- ✗Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
- ✗History of clinically significant Central Nervous System disease or neurological disorders
- ✗History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
- ✗Active clinically significant systemic bacterial, viral, parasitic or fungal infections
- ✗Active, chronic disease of the immune system other than MS
See the full criteria
Where Is This Study? (4 UK sites)
Novartis Investigative Site
Sheffield S10 2JF, United Kingdom
Novartis Investigative Site
Leeds LS1 3EX, United Kingdom
Novartis Investigative Site
London W6 8RF, United Kingdom
Novartis Investigative Site
Swansea SA6 6NL, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT