A study to evaluate the effectiveness and safety of remibrutinib in patients with secondary progressive multiple sclerosis

3 1

What is this study about?

This study is being conducted to evaluate the effectiveness and safety of a medication called remibrutinib, also referred to by the code name LOU064, in individuals living with secondary progressive multiple sclerosis. This condition is a type of autoimmune disease where the body’s immune system attacks the protective covering of nerves, leading to a gradual worsening of physical and cognitive functions over time.

Participants in this trial will receive either the study drug, remibrutinib, in the form of a film-coated tablet taken by mouth, or a placebo. The purpose of the study is to determine if this treatment can help delay the progression of disability. During the study, individuals will be monitored over a period of time to observe how the medication affects their physical abilities and overall health.

Who Can Join the Study?

  • You must provide a signed informed consent, which is a formal document where you agree to join the study after understanding all the details.
  • You must be a man or a woman between the ages of 18 and 65 at the time of the initial screening.
  • You must have a diagnosis of secondary progressive multiple sclerosis (SPMS), which is a stage of multiple sclerosis where symptoms gradually worsen over time.
  • Your diagnosis must meet the 2017 revised McDonald criteria, which is a specific set of medical rules used by doctors to confirm a diagnosis of multiple sclerosis.
  • You must not have had any clinical relapses, which are sudden increases in symptoms or new neurological problems, in the 24 months before starting the study.
  • Your EDSS score must be between 3.0 and 6.0. The Expanded Disability Status Scale (EDSS) is a method used by doctors to measure how much disability a person with multiple sclerosis has.
  • There must be documented proof that your disability has progressed, meaning your physical limitations have become more noticeable or severe, within the 12 months before the screening.

Who Cannot Join the Study?

  • You are unwilling or unable to have MRI scans, which are detailed pictures of the inside of your body taken with a large magnet. This includes people with claustrophobia (an extreme fear of enclosed spaces) or those with metallic implants, metallic foreign bodies, pacemakers, or defibrillators (devices implanted in the chest to control heart rhythm) that make it unsafe to be near a strong magnet.
  • You have a history of serious central nervous system (CNS) disease, which refers to issues with the brain or spinal cord, such as a stroke, a traumatic brain or spinal injury, or myelopathy (damage to the spinal cord).
  • You have other neurological disorders (problems with the brain or nervous system) that might look like multiple sclerosis (MS) during the initial health check.
  • You are currently struggling with substance abuse, such as drugs or alcohol, or have a serious psychiatric condition (a mental health disorder) that might make it difficult for you to follow the study rules.
  • You have a history of, or show symptoms of, Progressive Multifocal Leukoencephalopathy (PML), which is a rare and serious infection that affects the brain.
  • You are a woman who is capable of becoming pregnant and are not using highly effective contraception (birth control methods with a failure rate of less than 1% per year) while taking the study medicine and for at least one week after stopping it.
  • You have a high bleeding risk or coagulation disorders, which are conditions that prevent your blood from clotting properly.
  • You are using any of the specific exclusionary medications (medicines that are not allowed for this study) listed in the study rules.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Medical University Of Lausitz Carl Thiem Cottbus Germany
Hospital Vall d’Hebron Barcelona Spain
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Beaumont Hospital Dublin Ireland
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Fakultni nemocnice Motol a Homolka Prague Czechia
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Amsterdam UMC Amsterdam The Netherlands
Helse Bergen HF Bergen Norway
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
University Hospital Jena KöR Jena Germany
Centre Hospitalier Regional Universitaire De Tours Tours France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Sydvestjysk Sygehus Esbjerg Denmark
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Kepler Universitaetsklinikum GmbH Linz Austria
CHRU De Nancy Vandoeuvre Les Nancy France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero Universitaria Ospedali Riuniti Foggia Italy
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Lille Lille France
Klinikum der Universitaet Muenchen AöR Munich Germany
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
Region Midtjylland Aarhus Denmark
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Universitaet Leipzig Leipzig Germany
Centre Hospitalier Universitaire De Rennes Rennes France
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Rigshospitalet Copenhagen Denmark
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Oncopole Claudius Regaud Toulouse France
Universita Degli Studi Di Roma La Sapienza Rome Italy
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario De La Princesa Madrid Spain
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Medical Center Medconsult Pleven OOD Pleven Bulgaria
CHU Grenoble Alpes La Tronche France
Hospital Universitario Virgen De La Victoria Malaga Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Pauls Stradins Clinical University Hospital Riga Latvia
Fondation A De Rothschild Paris France
KBC Zagreb Zagreb Croatia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Clinical Medical Center Osijek Osijek Croatia
Groupe Hospitalier Nord Essonne Orsay France
Klinički bolnički centar Rijeka (Clinical Hospital Center Rijeka) Rijeka Croatia
Fakultni Thomayerova nemocnice Prague Czechia
Groupement Des Hopitaux De L’Institut Catholique De Lille Lomme France
Centre Hospitalier Et Universitaire De Limoges Limoges France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Tartu University Hospital Tartu Estonia
Besancon University Hospital Center Besançon France
University Medicine Greifswald Greifswald Germany
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
University Medical Center Ljubljana Ljubljana Slovenia
Helse Moere Og Romsdal HF Aalesund Norway
University Of Pecs Pecs Hungary
Pirkanmaan hyvinvointialue Tampere Finland
Pomeranian Medical University Szczecin Poland
Centre Hospitalier Universitaire De Poitiers Poitiers France
CHU Gabriel-Montpied Clermont Ferrand France
Rijnstate Ziekenhuis Stichting Arnhem The Netherlands
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
University Hospital Bratislava Bratislava Slovakia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Imelda Bonheiden Belgium
Krajska zdravotni a.s. Teplice Czechia
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Opca Bolnica Varazdin Varazdin Croatia
Neuro-Medic Sp. z o.o. Katowice Poland
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Clinexpert Kft. Budapest Hungary
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Neuropraxis Muenchen-Sued Unterhaching Germany
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Pratia S.A. Skorzewo Poland
Gyncentrum Sp. z o.o. Katowice Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi Lodz Poland
Hospital General Universitario De Albacete Albacete Spain
Uwcanhlvns Mesbdxxskfpa Hwudnkza Ffq Aghvis Tfhpyrdxb Adz Elbzopoqd Mcsbfcrm N I Pjgvkwe Sofia Bulgaria
Mqywlri Cgwkub Hacq Ejus Sofia Bulgaria
Unzwqtdwae Gygknde Hjwvfurt Ox Iyhuypkz Ioannina Greece
Pdzgipxqgcp Sxlgtl dvqqjv Zagreb Croatia
Fqfnrbdm Nzaszlisl Tbqwji Trnava Slovakia
Mfnoyetlkrie Hjymvuop Fvv Afjelj Tnizpwqvh Ip Nysghnokm Aan Pibmvjjlex Sgl Nyeq Ens Sofia Bulgaria
Aiwlokr Sgpar Syjcyluza Lpqyzr Nk 8 Dc Ckfjaeqt Cagliari Italy
Npewji Szb z oicw Rzeszow Poland
Kkrnadxzim Fkli Fjebcf Kkxpqh Kistarcsa Hungary
Sdpgazezj Kjoe Budapest Hungary
Nparopaug Sjvdeo Bucharest Romania
Male Nawqkkox Hwdww Hsutoznm Emc Sofia Bulgaria
Wmuqhjfofcreyzbvikyo Clmicmg Msdthuhh Iwkmmqd Svq Zabrze Poland
Hdoqijsx Oo Spr Pvoggk Fjfnqvshbtsjtmtr Rome Italy
Rrzoijhoyssv Sdhapjj lrwinywg Vwqgz Siauliai Lithuania
Dkoibekfiy Crwywaianekf Ciprjf 1u Sxtbd Eajb Sofia Bulgaria
Nglsmxlue Svi z ofwn Zory Poland
Cikkpl Hxkzikedtni Nkdtq Dgqz Db Li Myulcltachc Ajaccio France
Cfvbohxp Os Tallin Estonia
Bgkkgrdqphawxohpg Kbgmgp Eo Rrsktpcssgisyv Budapest Hungary
Axkzghe Shy z onyj Poznan Poland
Kvkbiiui Iovvsebqwnr gncat Ibbenbüren Germany
Eddvsyn sztjpq Bratislava Slovakia
Adhu ducqs Vilge Odpcn Pbxoirho Ohzbqyxfrrh Sm Amnaccp Acxdp dp Glqyishor Gallarate (VA) Italy
Narmyaewicms ag Khpjgasbnsui Itzehoe Germany
Pikmazfrpcqlsnkzox Mfiftjtqfuoyh Vienna Austria
Ibzinrxp Nvufuiskbvz Mdhpbqrscoit Nehxosmf Sldfes Pozzilli Italy
Syt Lsyrngbdrqwv Hogxpqqu Suux Thessaloniki Greece
Nhafzbiwgiou Bbbbzfhnl Sye z ojud Bydgoszcz Poland
Ewggepyn Hbxqxwpc Athens Greece
Snjwolyk Cvvbnr Crd Fkynjd Cccygkqhw Constanta Romania
Fosdttqorr Iynkvpln Ncgmkcsroyo Necfmtdog Csjklemf Muwkrcs Pavia Italy
Ultixgjvmw Hpcuqeqs Sqllb Duu Zagreb Croatia
Hvctqh Khvfzehy Ebmret Grqk Erfurt Germany
Jidyji Brsqk Zejwmhwlxp Srvquzkpy S-Hertogenbosch The Netherlands
Ulfstowmzmrri Karfgfcd Cfsigh Mfbxjad Maribor Slovenia
Kcewxaochoarg Nhcnv sfciyf Nitra Slovakia
Kvwobujwcisiobhoe Vffoehczu Shdyh Boufzvd Kkwmso Tatabanya Hungary
Cnorys Hekgqqznwer Gsaockg Gonesse France
Mwonlsartmoo Ktgcjuesfzz Hlfkbvxsihum gwmxj Halle (Saale) Germany
Ncbvcliwjo Gsqhelztbhgg fvi vsvhcefmlok Gusgqctywzughtsas Gker Ulm Germany
Mypprdhyygnbc Hvshuzxp fbh Aiuhzu Taixelqff Hhynm ahr Bjdha Edf Pleven Bulgaria
Nivkmloam Axlb Khxtahe sisylq Komarno Slovakia
Skyhizj Bhassdnwtm Cfmxk Celje Slovenia
Nedxquaidsav Sww z ofer Warsaw Poland
Cxffau Sobejksgw Smbemd Campulung Romania
Igyrqrbvvxob Pwqnrkcf Lzletevh Pvjly do havw ns moqy Kxjtiw Rypdlm Lublin Poland
Npecd Cchkxop Seguutq Gafh Erbach Germany
Vffqdlllarz Ild Smb z ozbr sfoog Cracow Poland
Pnleycfvc Bxcnv Kaxgvftmxfw Sncrr Wroclaw Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
05.02.2026
Belgium Belgium
Not yet recruiting
05.02.2026
Bulgaria Bulgaria
Recruiting
05.02.2026
Croatia Croatia
Recruiting
05.02.2026
Czechia Czechia
Recruiting
05.02.2026
Denmark Denmark
Recruiting
05.02.2026
Estonia Estonia
Recruiting
05.02.2026
Finland Finland
Not yet recruiting
05.02.2026
France France
Recruiting
05.02.2026
Germany Germany
Recruiting
05.02.2026
Greece Greece
Recruiting
05.02.2026
Hungary Hungary
Recruiting
05.02.2026
Ireland Ireland
Recruiting
05.02.2026
Italy Italy
Recruiting
05.02.2026
Latvia Latvia
Not yet recruiting
05.02.2026
Lithuania Lithuania
Recruiting
05.02.2026
Norway Norway
Not yet recruiting
05.02.2026
Poland Poland
Recruiting
05.02.2026
Portugal Portugal
Recruiting
05.02.2026
Romania Romania
Recruiting
05.02.2026
Slovakia Slovakia
Recruiting
05.02.2026
Slovenia Slovenia
Recruiting
05.02.2026
Spain Spain
Recruiting
05.02.2026
Sweden Sweden
Recruiting
05.02.2026
The Netherlands The Netherlands
Recruiting
05.02.2026

Trial locations

Investigated Drugs:

Remibrutinib is an oral tablet being tested to see if it can help slow down the progression of physical disability in people living with secondary progressive multiple sclerosis.

Secondary progressive multiple sclerosis – This is a form of multiple sclerosis characterized by a steady worsening of neurological functions over time. It typically follows an initial period of clearly defined attacks or episodes of neurological symptoms. Unlike other forms, the physical or cognitive impairments gradually increase without distinct periods of recovery. The progression involves ongoing damage to the protective covering of nerve fibers in the central nervous system. This damage can lead to difficulties with movement, coordination, and sensation.

Trial ID:
2025-521546-23-00
Protocol code:
CLOU064P12301
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis

    Recruiting

    3 1 1
    Austria Belgium Bulgaria Croatia Czechia Denmark +17
  • Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis

    Not yet recruiting

    1 1 1 1
    France Germany Italy Spain