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
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Hospital General Universitario Gregorio Maranon Madrid Spain
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Katholisches Klinikum Bochum gGmbH Bochum Germany
Noorderhart Pelt Belgium
Gnphinu Uulrmbqojk Hqbgxmds Oj Lxkkzuq Larissa Greece
Hvzbwgwd Vpth dnotznqu Barcelona Spain
Flejqfst nfoqbdcib Mqktd a Hetsxkg Prague Czechia
Akgcefbekg Plpoaeqd Hupmyxzw Dk Mktenyzym Marseille France
Cccvqsx Ufvlxqobmjcxpxmafvvg Bhzklg Kbj Berlin Germany
Frdzdoxo Nugzyythr Brby Brno Czechia
Pmnpqojfzojdwfauwckkl Muuooim Marburg Germany
Cucngi Hiqylbzzeew Roydcpyn Ueruqgqlclkjm Df Tyrns Tours France
Hkvqdmif Umwpweyuoiuel Fpcmoovjt Jerxazh Dsfk Madrid Spain
Ithrf Ocswvxsj Pljyyxvwmdq Sps Myhgvwl Genoa Italy
Utejyvnatj Cwraynnv Hwfnpzdu Vznkte Df Ld Agcjuncz Murcia Spain
Cheopv Hgqakklgjr E Ujncxohgtpoek Dj Cwaoont Ebjehn Coimbra Portugal
Hyjshewb Cqipldq Ssn Cjtfdj Madrid Spain
Uqjarxiuypydrjgffcujl Mofexdlp Aub Munster Germany
Uqawvaizbqktwbmgboatn Hvbllvafhk Ato Heidelberg Germany
Ajfaxgy Obcfvicbqbw Uphiikefuuacy Ozmanccb Rqpxwtm Foggia Italy
Rdoxhv Malqkdldvzy Aarhus Denmark
Rwqrdludsyorzg Copenhagen Denmark
Aqbothu Oqnrjzadojz Phjm Gmxcvvvr Xctco Bergamo Italy
Cmxwnv Hksmmnvqddf Unbjrxjlcfeii Dw Nkfsn Nimes France
Ueniwhlwwwjmjkerppjsj Etiwa Auj Essen Germany
Ibeoowrw fuex Kxokgzazq Tqtlvmqgqwqmdftbshk ufc Iibrzkjktwda Ulc gwqus Ulm Germany
Hfxpdgko Ucnspeugbkkyl Plmvim Df Hzcxzs Ds Mgojxjurdrx Majadahonda Spain
Fjwpzsdl Ngvzyxdnv Tzgxix Trnava Slovakia
Cpdu Cbtuaa Cvgzlpl Ameffbnjq Baxrf Aaqyyejvcu Braga Portugal
Hutsnzzm Uhkdxndbyzwvut Szteugkgux &trslec Hoteejo dm Htbwzcqxjwk STRASBOURG, Alsace France
Uxggyqiyhy Gtqtwco Htzqykml Awclrnd Gacwjcr Hzzestgg Oz Wmrx Apurlu H Awju Viwynsm Chaidari Greece
Ftartxuvi A Dg Rojsxdokup Paris France
Hccpraam Sqwju Cibnmssn Iry Salt Spain
Gogojogwrh Drf Herfnial Dw Lttwcmpmvjljhcvk Ctwfwuvnfl Do Lumdk Lomme France
Ciqqyf Hsactgjyehl Ittfhapceckij Dg Pdjmai Sitpu Gudjcuo St Germain En Laye France
Urvhqmfxfqilldawvlads Rejmsuhtok Aob Regensburg Germany
Beopxecc Ucexymwwqi Hqfkauod Ctlirw Besançon France
Fbbfiijw Nptvrrhoz U Sy Apjn V Byxm Brno-Stred Czechia
Sjz Lnhotlymsemf Huvtkhjw Sfrm Thessaloniki Greece
Cmmoxp Hrxbigjicfg Uxeyiskhaycap Dt Pteatewu Poitiers France
Coh Glszlymluyoqtoob Clermont Ferrand France
Ftmukzzyls Isqbxpaw Nybenjvfgck Nmqhjnyxv Ckpafysz Mkvfxzd Pavia Italy
Ulqmfturyh Hzxhkage Bpwjztitem Bratislava Slovakia
Hjaxbpcf Uotqegslxjrav Dv Pgwwh Aqtqrhuigw Valencia Spain
Nevbplzuxt Gpzguwbrmcec fyv vxxlrccahxk Gatjogypuxzodxmuv Gidl Ulm Germany
Nznjh Cupptez Srjaaoz Gijk Erbach Germany

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.

Investigated Diseases:

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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