NCT06846281RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 24 Feb 2025
- Start date
- 23 Jun 2025
- Primary completion date
- 25 Jul 2029
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT06846281
- EU CT number
- 2023-509275-17-00
- EudraCT number
- 2023-509275-17
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 23 Jun 2025 to the primary completion date, 25 Jul 2029
- 132 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)
- Other inclusion and exclusion criteria may apply
Other
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
- Participant who is unable to undergo MRI scans
Who 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
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (132)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Liverpool | Australia | Withdrawn |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Noorderhart Coordinator of this site? Confirm its status | Pelt | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Joinville | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Lévis | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| - Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| - Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Nemocnice Jihlava prispevkova organizace Coordinator of this site? Confirm its status | Jihlava 1 | Czechia | Recruiting |
| Nemocnice Pardubickeho kraje a.s. Coordinator of this site? Confirm its status | Pardubice | Czechia | Recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Neuro Centrum Science GmbH Coordinator of this site? Confirm its status | Erbach | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Santa Caterina Ias Coordinator of this site? Confirm its status | Salt | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Universitaire de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Intercommunal De Poissy Saint Germain Coordinator of this site? Confirm its status | Poissy | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| - Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Swansea | United Kingdom | Recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Fakultna nemocnica Trnava Coordinator of this site? Confirm its status | Trnava | Slovakia | Recruiting |
| University of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Neurology of Central FL Res Ctr Coordinator of this site? Confirm its status | Altamonte Springs | United States | Recruiting |
| Austin Regional Clinic Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Withdrawn |
| SUNY Buffalo The Jacobs Neuro Inst Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Lahey Hospital and Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| Premier Health Coordinator of this site? Confirm its status | Centerville | United States | Recruiting |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Univ of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Ohio Health Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Univ of Texas Southwest Med Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Sanford Health Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Michigan Institute of Neurological Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| John Peter Smith Hospital Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Neurology Center of New England, PC Coordinator of this site? Confirm its status | Foxborough | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Center for Neurological Disorders G Coordinator of this site? Confirm its status | Greenfield | United States | Recruiting |
| Premier Neurology Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Memorial Healthcare System Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Kansas Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Sibyl Wray MD Neurology PC Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Neurology Associates PA Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| Elite Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Aqualane Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Medstar Montgomery Medical Center Coordinator of this site? Confirm its status | Olney | United States | Recruiting |
| Orlando Health Clinical Trials Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Advent Health Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Memorial HC Ins for Neuroscience Coordinator of this site? Confirm its status | Owosso | United States | Recruiting |
| Saturn Research Solutions LLC Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Providence Neurological Services West Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Perseverance Research Center Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| WA Uni School Of Med Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Tallahassee Neurological Clinic Coordinator of this site? Confirm its status | Tallahassee | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Holy Name Medical Center Coordinator of this site? Confirm its status | Teaneck | United States | Recruiting |
| Vero Beach Neurology Coordinator of this site? Confirm its status | Vero Beach | United States | Recruiting |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| - Coordinator of this site? Confirm its status | Pretoria | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.