No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for people with relapsing multiple sclerosis who have been treated with ocrelizumab and want to switch to remibrutinib. Participants will take remibrutinib and their health will be monitored.
Are You a Good Fit for This Trial?
Must be takingOcrelizumab
You may be able to join if
I am between 40 and 70 years old.
I have been diagnosed with relapsing multiple sclerosis.
I have been treated with ocrelizumab.
I am neurologically stable within the last 30 days.
My doctor believes I can switch to remibrutinib.
You may not be able to join if
I have primary progressive multiple sclerosis.
I have a history of significant central nervous system diseases.
I have had progressive multifocal leukoencephalopathy.
I have active infections that are serious.
I have a chronic immune system disease other than MS.
I have severe heart disease.
I cannot have MRI scans.
I didn’t respond well to ocrelizumab.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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).
Trial Locations
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Status
Eligibility Criteria
Key Inclusion Criteria:
* 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 r…
Key Inclusion Criteria:
* 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
Key Exclusion Criteria:
* 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
* Severe cardiac disease or significant findings on the ECG
* Participant who is unable to undergo MRI scans
* 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
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