Remibrutinib After Switching From Ocrelizumab in Relapsing Multiple Sclerosis
Tests remibrutinib pill after switching from ocrelizumab in adults with relapsing multiple sclerosis.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Leeds, London, Sheffield, and Swansea, United KingdomSee the 4 sitesAlso in 18 other countries, 128 sites
- Trial code
- Registry title
- Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 400 people, planned
- Started
- 23 Jun 2025
- Expected to end
- 25 Jun 2031
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Remibrutinib oral treatment
- Ocrelizumab
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsing multiple sclerosis who are already treated with ocrelizumab. It tests switching to remibrutinib compared with staying on ocrelizumab.
- Age
- 40 to 70 years
- Sex
- Men and women can join.
- Disease stage
- Relapsing multiple sclerosis diagnosed by the 2017 McDonald criteria. Neurologically stable within 30 days.
- Earlier treatment
- Must be treated with ocrelizumab at the standard dose in routine care. Must not have had a life-threatening infusion or injection reaction to ocrelizumab.
- Biomarker or test result
- CD19+ B-cell count must be below 10 cells/µL at screening.
Main reasons for not taking part
- Primary progressive multiple sclerosis
- Active serious infection, or past progressive multifocal leukoencephalopathy
- Other active, chronic immune system disease
- Severe heart disease or significant ECG findings
- Cannot have MRI scans
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
- 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
- Severe cardiac disease or significant findings on the ECG
- History of life-threatening infusion or injection reaction related to ocrelizumab
- Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening); Other inclusion and exclusion criteria may apply
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
- Participant who is unable to undergo MRI scans
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
Where in United Kingdom
Also in 18 other countries, 128 sites
- Leeds, West YorkshireHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- LondonHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- SheffieldHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- SwanseaHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
About the trial
What the trial wants to find out
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).
The 4 groups in the trial
- Remibrutinib CoreTreatment being tested
Remibrutinib tablet taken orally
Treatment: Remibrutinib oral treatment
- Ocrelizumab CoreExisting treatment, for comparison
Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
Treatment: Ocrelizumab
- Remibrutinib ExtensionTreatment being tested
Remibrutinib tablet taken orally
Treatment: Remibrutinib oral treatment
- Remibrutinib Extension (Ocrelizumab in Core)Treatment being tested
Remibrutinib tablet taken orally
Treatment: Remibrutinib oral treatment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib
- Plain-language title
- Remibrutinib After Switching From Ocrelizumab in Relapsing Multiple SclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06846281, who can take part
- Record updated
- 26 October 2026