Remibrutinib After Switching From Ocrelizumab in Relapsing Multiple Sclerosis
Tests remibrutinib pill after switching from ocrelizumab in adults with relapsing multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Key facts
- Where
- Bergamo, Foggia, Genoa, Milan, Pavia, and Rome, ItalySee the 7 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT06846281, who can take part
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
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?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06846281EU 2023-509275-17-00
- Record updated
- 26 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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.