Study comparing remibrutinib and ocrelizumab in patients with relapsing multiple sclerosis who switch from ocrelizumab treatment

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What is this study about?

This study focuses on people with Relapsing Multiple Sclerosis, a condition where the immune system attacks the protective covering of nerve cells, causing episodes of neurological symptoms. The study compares two medications: remibrutinib, a new oral medication that works by blocking a specific protein called Bruton’s tyrosine kinase, and ocrelizumab, an existing treatment that is given either through an infusion into a vein or as an injection under the skin.

The main purpose of this research is to determine if remibrutinib is as effective as ocrelizumab in controlling disease activity as seen on magnetic resonance imaging (MRI) scans. The study will look at patients who are currently using ocrelizumab and switch them to either continue ocrelizumab or start taking remibrutinib. The study will track participants’ progress for 24 months to compare how well both treatments work.

During the study, participants will receive either remibrutinib tablets taken by mouth or ocrelizumab given through injection or infusion. Doctors will monitor participants’ health through regular check-ups and MRI scans to track any changes in their condition. After the initial 24-month comparison period, all participants will have the opportunity to receive remibrutinib for an extended period.

1 Initial screening and baseline assessment

A medical evaluation will be performed to confirm eligibility for the study

An MRI scan will be taken to establish baseline brain imaging

Your current multiple sclerosis status will be assessed

2 Treatment assignment

You will be randomly assigned to receive either remibrutinib (taken as oral tablets) or continue ocrelizumab treatment

If assigned to remibrutinib, you will switch from your current ocrelizumab treatment to taking tablets by mouth

If assigned to ocrelizumab, you will continue receiving it through intravenous (into the vein) or subcutaneous (under the skin) injection

3 24-month main study period

Regular medical assessments will monitor your health status

MRI scans will track any changes in brain lesions

Your physical abilities will be evaluated to check for any changes in disability

Blood tests, vital signs checks, and heart monitoring (ECG) will be performed

Any symptoms or health changes will be recorded

4 Extension period

After the main study period, you may continue in an extension phase

During this time, monitoring will continue with regular health assessments

MRI scans will continue to track brain lesions

Safety monitoring will include blood tests, vital signs, and heart activity checks

Who Can Join the Study?

  • Must sign an informed consent form before any study procedures begin
  • Must be 40 years or older at the time of screening
  • Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS) according to the 2017 McDonald criteria
  • Must be currently receiving treatment with ocrelizumab (a medication used to treat multiple sclerosis) at standard doses as part of regular medical care
  • Must be neurologically stable for at least 30 days before screening, which means:
    • No MS relapses (periods when symptoms get worse) during this time
    • No significant changes in neurological symptoms
  • Must be considered suitable by their doctor to switch to the study medication remibrutinib, or have a personal preference to make this change
  • Both men and women can participate in the study

Who Cannot Join the Study?

  • History of other neurological conditions besides multiple sclerosis
  • Current pregnancy or breastfeeding
  • Severe allergic reactions to similar medications in the past
  • Active serious infections, including hepatitis B or tuberculosis
  • Significant heart problems or uncontrolled high blood pressure
  • History of cancer in the past 5 years (except for successfully treated skin cancer)
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or abnormal kidney function
  • Recent live vaccinations (within 6 weeks before starting treatment)
  • Current participation in other clinical trials
  • Inability to undergo MRI scans (magnetic resonance imaging – a type of medical imaging that uses magnetic fields)
  • History of drug or alcohol abuse within the past 6 months
  • Mental health conditions that could interfere with following study procedures
  • Taking medications that could interact with the study drug
  • Blood disorders or significant abnormalities in blood tests

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
CHU Gabriel-Montpied Clermont Ferrand France
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
University Hospital Bratislava Bratislava Slovakia
Katholisches Klinikum Bochum gGmbH Bochum Germany
Fakultna Nemocnica Trnava Trnava Slovakia
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Noorderhart Pelt Belgium
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Fondation A De Rothschild Paris France
General University Hospital Of Larissa Larissa Greece
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Universitaetsklinikum Regensburg AöR Regensburg Germany
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Philipps-Universitaet Marburg Marburg Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire De Nice Nice France
St. Luke’s Hospital S.A. Thessaloniki Greece
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Neuro Centrum Science GmbH Erbach Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Hrvtswuz Sdonj Coiskspv Igb Salt Spain
Upozswxkwhsbnunickcji Edqrh Adf Essen Germany
Fvdtjyrq neebeqeke Mkjgd a Hwfhauj Prague Czechia
Abmumghaky Poewknup Hstnvofy Db Meujreuwm Marseille France
Bnbabgel Ujpgsstzqp Hlmoyawm Crkkla Besançon France
Cfpcky Hfjhuqmemaa Rtnqijdd Uijhokyelftgu Dl Txtud Tours France
Ugmouelfcyupakgzhtcso Mxpfaxgj Azs Munster Germany
Aqdubjx Oqthmsffhzx Ucgxvhryefswh Ogsgxegf Rwpnpnu Foggia Italy
Ahkohgj Oybgntxinqq Picc Gztgiydr Xdzsc Bergamo Italy
Hlhmjxpi Vrrr dumxvpyi Barcelona Spain
Hdfiazqk Umaiemlsetilac Sxocpjyxrw &naxqdl Hdmymao dt Hfyedjzvqwo STRASBOURG, Alsace France
Cwxeyc Hhizngdtke E Uxepejsohxlab Do Cowzdrd Esqhmt Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.10.2025
Czechia Czechia
Recruiting
01.10.2025
Denmark Denmark
Recruiting
01.10.2025
France France
Recruiting
01.10.2025
Germany Germany
Recruiting
01.10.2025
Greece Greece
Recruiting
01.10.2025
Italy Italy
Recruiting
01.10.2025
Portugal Portugal
Recruiting
01.10.2025
Slovakia Slovakia
Recruiting
01.10.2025
Spain Spain
Recruiting
01.10.2025

Trial locations

Investigated drugs:

Remibrutinib is a medication being studied for treating relapsing multiple sclerosis. It belongs to a class of drugs known as BTK inhibitors, which work by blocking specific proteins involved in inflammation. This medication aims to control the inflammatory activity in the brain and spinal cord of people with multiple sclerosis.

Ocrelizumab is an established medication used to treat relapsing multiple sclerosis. It works by targeting and reducing specific B cells in the immune system that are thought to contribute to nerve damage in multiple sclerosis. It is given through an intravenous infusion and is currently used as a standard treatment for multiple sclerosis.

Multiple Sclerosis (Relapsing) – A chronic neurological condition where the immune system attacks the protective covering of nerve fibers in the central nervous system. In the relapsing form, people experience distinct episodes of symptoms followed by periods of partial or complete recovery. During relapses, inflammation causes new damage to nerve cells, leading to various symptoms such as vision problems, muscle weakness, and coordination difficulties. Between relapses, patients may feel relatively well, though some symptoms might persist. The disease typically follows a pattern where new symptoms appear or existing ones worsen during relapses, which can last days to weeks.

Trial ID:
2023-509275-17-00
Protocol code:
CLOU064C12306
NCT ID:
NCT06846281
Trial Phase:
Therapeutic confirmatory (Phase III)

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