Orelabrutinib in Patients with Primary Progressive Multiple Sclerosis

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What is this study about?

This clinical trial is studying Primary Progressive Multiple Sclerosis (PPMS), a form of multiple sclerosis that slowly gets worse over time. The treatment being tested is orelabrutinib, an oral tablet taken by mouth, and it is being compared with placebo tablets that look the same. The purpose of the study is to see whether orelabrutinib can help delay disability getting worse in people with PPMS.

People in the study are assigned by chance to receive either orelabrutinib or placebo. The study is set up so that neither the participants nor the study doctors know which treatment is being given during the trial. Treatment is taken over time, and the study follows participants to see how their condition changes during the study period.

PPMS can affect walking, balance, hand use, and other body functions. Disability progression means a gradual increase in these problems. The study is designed to compare how often this worsening happens in the two groups.

Who Can Join the Study?

  • Be 18 to 60 years old when signing the informed consent form, which is the document that explains the study and shows that the person agrees to join.
  • Have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) based on the McDonald criteria, which are medical rules doctors use to confirm multiple sclerosis.
  • Have documented evidence that disability has gotten worse over the 24 months before screening, and this worsening must be independent of clinical relapse, meaning it happened without a sudden attack or flare-up of symptoms.
  • Have an EDSS score between 3.0 and 6.5 at screening. The EDSS, or Expanded Disability Status Scale, is a score doctors use to measure how much multiple sclerosis affects movement and daily activities.

Who Cannot Join the Study?

  • Having relapsing-remitting multiple sclerosis (RRMS), which means MS with attacks or flare-ups followed by periods of recovery.
  • Having secondary progressive multiple sclerosis (SPMS), which means MS that started with relapses and later became steadily worse.
  • Having an immune system disorder other than MS, or having any condition that needs treatment with corticosteroids by mouth, by vein (intravenous), by muscle injection (intramuscular), or by injection into a joint (intra-articular).
  • Having another neurological disorder in the past or now that could look like MS. A neurological disorder is a disease of the brain, spinal cord, or nerves.
  • Having any other serious active medical condition, meaning a significant health problem that is currently present and may affect study participation.

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 Rouen Rouen France
General University Hospital Of Larissa Larissa Greece
Medical Center Hera EOOD Sofia Bulgaria
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier Universitaire De Nice Nice France
Region Midtjylland Aarhus Denmark
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Univerzitna Nemocnica Martin Martin Slovakia
Uniklinikum Salzburg Salzburg Austria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Fondation A De Rothschild Paris France
KBC Zagreb Zagreb Croatia
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
401 General Military Hospital Of Athens Athens Greece
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Clinexpert Kft. Budapest Hungary
Novo-Med Zielinski I Wspolnicy Sp. j. Katowice Poland
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Spitalul Clinic De Psihiatrie Si Neurologie Brasov Brasov Romania
Diagnostic Consultative Center 14 Sofia EOOD Sofia Bulgaria
Gornoslaskie Centrum Mwdyczne Katowice Poland
Clinic4U OÜ Tallin Estonia
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Universitaetsklinikum Regensburg AöR Regensburg Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Hospital Universitario De Cruces Barakaldo Spain
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Pratia S.A. Skorzewo Poland
St. Luke’s Hospital S.A. Thessaloniki Greece
University Hospital Olomouc Olomouc Czechia
Eginitio Hospital Athens Greece
Pirkanmaan hyvinvointialue Tampere Finland
Spitalul Clinic Cai Ferate Constanta Constanta Romania
Hospital Alvaro Cunqueiro Vigo Spain
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Barmherzige Brueder Trier gGmbH Trier Germany
St. Josef-Hospital Bochum Germany
University Hospital Bratislava Bratislava Slovakia
Mtz Clinical Research Powered By Pratia Warsaw Poland
Krajska zdravotni a.s. Teplice Czechia
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Noorderhart Pelt Belgium
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Neurohk s.r.o. Chocen Czechia
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
Centre Hospitalier General Gonesse France
Unidade Local De Saude De Entre O Douro E Vouga E.P.E. Santa Maria Da Feira Portugal
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
Medical Center Medica Plus Ltd. Veliko Tirnovo Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Multiprofile Hospital For Active Treatment Avis Medika OOD Pleven Bulgaria
Henry Dunant Hospital Center Athens Greece
Neuroprotect Sp. z o.o. Warsaw Poland
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov Presov Slovakia
Clinirem Sp. z o.o. Lublin Poland
Medical Center Nevrocentrum EOOD Plovdiv Bulgaria
Gemeinschaftspraxis fuer Neurologie Dr. med. W. Blersch und Dr. med. J. Redelstein Regensburg Germany
Neuro Centrum Science GmbH Erbach Germany
Zana-Med Medical Group Sp. z o.o. Lublin Poland
Euromedis Sp. z o. o. Szczecin Poland
Hbcjpcst Uyzecylrtitkd dp A Cvnryx A Coruna Galicia Spain
Uuzfpjqkfusifgesxdjzx Msogjgfc Aoh Munster Germany
Crkz Do Njlna Vandoeuvre Les Nancy France
Ufnuwejmblsnqloqixtee Eewlu Ays Essen Germany
Hyeeizep Uakxyuyotcctlh Srwpvmlurh &pdfbsi Hhhamvo dh Hzjbjsidtdk STRASBOURG, Alsace France
Nbssvm Siw z oynm Rzeszow Poland
Mgktk Bgewk Drrwjare niywwexckimw aopniorhuu sdzvdu Banska Bystrica Slovakia
Hmyqlxwn Sfjgp Cbxpaftj Iif Salt Spain
Gzakln Hbzivvcksvo Nzay Emsfgkt Orsay France
Nlyoawaqc Skn z oswm Zory Poland
Phq Skadh Sco z oxaq shero Lodz Poland
Uwbabssqelvgn Swekqiq Koirmmwuu W Oqvzquezu Olsztyn Poland
Ksnleviv Bzgnpttv Guyn Bayreuth Germany
Nxcwjkewk Mylucfax Ssupnwkh Cuszakv Vkowrg Steenokkerzeel Belgium
Hcmwmdti Uiluzzcohaugx Hbputovn Tgate y Pzhfij Isoookbv Cpylob doqtyhcjaeitenins (ybdp Badalona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
29.05.2026
Belgium Belgium
Recruiting
29.05.2026
Bulgaria Bulgaria
Recruiting
29.05.2026
Croatia Croatia
Recruiting
29.05.2026
Czechia Czechia
Recruiting
29.05.2026
Denmark Denmark
Recruiting
29.05.2026
Estonia Estonia
Recruiting
29.05.2026
Finland Finland
Recruiting
29.05.2026
France France
Recruiting
29.05.2026
Germany Germany
Recruiting
29.05.2026
Greece Greece
Recruiting
29.05.2026
Hungary Hungary
Not yet recruiting
29.05.2026
Italy Italy
Recruiting
29.05.2026
Poland Poland
Recruiting
29.05.2026
Portugal Portugal
Recruiting
29.05.2026
Romania Romania
Recruiting
29.05.2026
Slovakia Slovakia
Recruiting
29.05.2026
Spain Spain
Recruiting
29.05.2026
Sweden Sweden
Recruiting
29.05.2026
The Netherlands The Netherlands
Recruiting
29.05.2026

Trial locations

Orelabrutinib is an oral tablet taken by mouth in this study. It is the main study medicine being tested to see whether it can slow down disability getting worse in people with primary progressive multiple sclerosis. The trial is looking at how well it works and how safe it is compared with placebo.

Primary progressive multiple sclerosis – A form of multiple sclerosis in which symptoms steadily worsen from the start rather than appearing in repeated attacks. It mainly affects movement, balance, strength, and coordination, and the changes usually build up gradually over time. Walking may become slower and more difficult, and hand use may also become less precise.

Trial ID:
2025-524316-11-00
Protocol code:
ZB020-03-001
NCT ID:
NCT07067463
Trial Phase:
Therapeutic confirmatory (Phase III)

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