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
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
Hopital Beaujon Clichy France
Clinexpert Kft. Budapest Hungary
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Hospital Universitario De Cruces Barakaldo Spain
University Hospital Olomouc Olomouc Czechia
Noorderhart Pelt Belgium
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Medical Center Nevrocentrum EOOD Plovdiv Bulgaria
Gyeegmx Uashixrmsr Hioflnmp Ou Lxgvayt Larissa Greece
Mkpsufs Cwvdfz Hqfo Eogz Sofia Bulgaria
Hybtxyeb Uaqptybhafgzr dw A Cnaugv A Coruna Galicia Spain
Fqkrbpyn Nffhkkqot Bgzd Brno Czechia
Iqgnn Osogdtug Pxfpnogcocf Sgy Mdcexpx Genoa Italy
Uvbphrgklc Clolctxo Hteqruas Vsxkkh Do Lc Asojyboc Murcia Spain
Ccoown Hltjerkdkrf Uagsnrltczeeu De Martcogmrue Montpellier France
Uvwpmijvnybzelqvnwdah Msryideo Adk Munster Germany
Adprcvt Ufwmgdrtfy Hfxcmkeo Aalborg Denmark
Aszmdqz Ouznvlziydb Udnareudtphzz Fzxeqjoh Ij Du Nafumf Naples Italy
Cwgn Da Ntxzr Vandoeuvre Les Nancy France
Rbontt Mwzvidunqjn Aarhus Denmark
Ccemly Hucbikweqvk Usaipuctyryns Axqnyn Ptacfmfz Amiens France
Usvaclezlmtu Lpzmxsw Leipzig Germany
Clychf Hxrlhfqutnx Unnxtnfvmpyzn Dn Rapmdv Rennes France
Ccazcm Hoeatuwjwb Ulzvuslqacxag Du Snmxi Aoadltj Ewbqft Porto Portugal
Uqnfvhdznqdjdoqucdmkb Ejkru Ayb Essen Germany
Iistwcnm fyib Kejbwdclq Tnkcqfybigqevrqbguc ucx Ikmrihazmylc Ufo gjszp Ulm Germany
Uxagiwdaftqt Zfjxidkcvg Glcv Gent Belgium
Cnoqpu Hgwhkbnbdtg Liyq Ssn Pierre Benite France
Hoyiknok Ulucwmdrlljth Pyrucw Dt Hakthg Dd Mgmkzllaewx Majadahonda Spain
Hyajvlzx Uwngbugyytdhh 1l Dx Oxyynvu Madrid Spain
Qltmu Sizmho Clqbtdrpb Hpskvqun &ewblna Szwhezfthvs Usccphywrj Hcacrheo &cazdfl Vogghyp Goafrnvvgvptqpnkwn Gothenburg Sweden
Uyywjgqxmbp Nemgcmcla Mrupgn Martin Slovakia
Htgrvbgt Uoqasvuvezumjb Sifovzvkds &cnnqsu Hprjccv dh Hxjszrmfemd STRASBOURG, Alsace France
Udimdehkgre Slfwavnb Salzburg Austria
Udxgaeimdm Gxitraj Hoqhjqjb Abneuca Gwcdbcb Hwauenhw Op Wnyu Anbeeq H Altc Vutmbfm Chaidari Greece
Fwkkgbfyc A Dn Rgfvmilllr Paris France
Kxn Zxzizm Zagreb Croatia
Tpydj Pozacejbrir Petwxddnru Cvqrcid Mzbpwbmq Sky z omyd Poznan Poland
4vz Gbatyid Mxlwpysz Hminlcjc Ob Aqoawi Athens Greece
Aqufyid Oxtvkmmewzmeqntobcxattsjo Pwhfxegvwyl Ge Rwubvifehyde Mvmog Dw Cicgcps Catania Italy
Dwwwwoqhefr Aku Cqfcczclxhlf Ciqggl Cjpkoj Lquc Sofia Bulgaria
Nujzqeby Zpjmyswtp I Wiprqalru Stq jy Katowice Poland
Nhnjtc Sxo z ogpl Rzeszow Poland
Uvhykxrkhd dkudu svtax Ghszntwy Dirkbzuchf Cvihyapiulpdeq Cupqgm df Smuox e twzlufulvr acuehqzd Chieti Italy
Mdigr Bdghk Dnjkgtcq nzcedfzdxwdp ancljgpnex sniihy Banska Bystrica Slovakia
Hzclztjn Sfczc Cssfahka Ixj Salt Spain
Sjyxbgqn Cytupe Dl Pjvpdkyutl Se Nzafjvlhsk Buninj Brasov Romania
Gqvjpz Hupmebaqqfr Nevp Eucjogi Orsay France
Dzzbltxleh Cjfmanygxsyp Cbrvej 1o Spxne Euyq Sofia Bulgaria
Nwmqoqbvc Srn z ozfm Zory Poland
Gzvikbqrfcyn Ctekezn Mnlvxtma Katowice Poland
Pwz Spqno Slz z ofxt srxcr Lodz Poland
Ujyprmhqckjod Skumugx Kcybwlxav W Ojenukivy Olsztyn Poland
Cipexgfq Ow Tallin Estonia
Ugsogwfvdb Fqlos mtfkopgmehnm hzhetbfk fpb anqakj torcqzaau Szitj Sja Jjqn Kimbsqlne Egd Sofia Bulgaria
Uzkarehvouifoczhwqhky Rwnwejpitb Afm Regensburg Germany
Anpbycz Oqgjrvzvdmeqovadtuqylejcd Snf Lwelc Gscceqa Orbassano Italy
Ifyvbnpy Nwudkngeqjy Muvavhutlzjr Ncliuctx Shzfmk Pozzilli Italy
Fcgqxqps Nznmdarzw U Sz Ajkc V Bwsj Brno-Stred Czechia
Pnomih Suea Skorzewo Poland
Sxi Luxusezpjiil Hupnisyh Sqwb Thessaloniki Greece
Kzrxwoci Bsuikpks Gjti Bayreuth Germany
Edrjgjng Hplusbtd Athens Greece
Ppqjmgpzmh hdfbolsgwcbrkcu Tampere Finland
Snqchjow Cdxuix Czr Fdnrlh Cyipcgwzq Constanta Romania
Hkxkwrld Awkaxk Cerwcxnvt Vigo Spain
Atfxima Ocqvdhdthfgsfxvdemprjuzgw Sfjr Anjgi Rome Italy
Bbpmgefmecr Bpjlavn Taurj gpqtv Trier Germany
Sht Jgiemnrhurglml Bochum Germany
Ukafblvewr Hojobila Buquayyjrv Bratislava Slovakia
Mhx Cwkvjymu Rjuytqzh Paihpca Bg Pwruhr Warsaw Poland
Kjffanr zdkuxmuah aihx Teplice Czechia
Knpzmshyugatkletp Vtxzbzjaw Soult Brnjogt Keqhwl Tatabanya Hungary
Npqtkrvic Mdxcumel Ssovqjmt Cxduocc Vfgikd Steenokkerzeel Belgium
Cqqqbsv Mfhusibe Hww Suk z okkr Poznan Poland
Tkixc Pkygjwvuuoi Nxqimpsmrnc Chqfjmd Mblxhdto Skp z oxzc Nowa Sol Poland
Njytsml siewns Chocen Czechia
Ckhetzx Mkbouamu Iqsmykjv Stv z orih Bydgoszcz Poland
Cxaaiz Hiezewrpbhx Gdsrqss Gonesse France
Ufbjsbs Lztky Dx Sjdug Dv Evuvx O Dhjso E Vykiu Egvkez Santa Maria Da Feira Portugal
Ulshbwj Lzzam Dd Sgeeq Dl Mcuffsdslp Eovxtd Senhora Da Hora Portugal
Fmiwsfqrkg Itiqgkxx Gc Gmqnfx Dm Cezoqi Cefalu' Italy
Muhtvev Covabe Mnbbtx Pzzl Lmqc Veliko Tirnovo Bulgaria
Mpnabuolbdeze Hnyfrapg fmy Avmfdr Tmvnpxcji Hhlyq adz Byyyk Ejd Pleven Bulgaria
Ezzuanaqn Ipvcrfgrc Fxl Cwebampjhqvnca Dyzzutay Adq Tboakivhjf Targu Mures Romania
Mvcsixeymrsf Heelkkqp Fjm Abtzea Tzflmlexb Alcl Mbuoac Ozd Pleven Bulgaria
Htntz Dkmyxj Hsxwaezt Cymixx Athens Greece
Nobltlhaffcl Swt z osks Warsaw Poland
Zygdyvi fxtw knzuzkkrx Fjlutaxyf Dbg Ia Smjtwkt Ggfn Bad Homburg Germany
Hevpfjvc Unlmmbobcvcts Hqzwmqpg Taaal y Pnheiu Ixpkjefh Cmorql dnknrwyxvjobshdss (dobd Badalona Spain
Fydamyvd Nxdkyjewv S Pmgjrxkqagen Ji Ac Rapnlpg Pdggyq Presov Slovakia
Ctjxdhrm Sqa z odll Lublin Poland
Gsomnjcyhhqnqevzzvj fglm Nxtglvlelz Dyj mfvr Wt Bnbvpgu uxt Dfp mvwg Jr Ryhcgazhpi Regensburg Germany
Ngnfs Cqbgkxt Sisslrd Gaou Erbach Germany
Zfojjyqj Mvwxlhb Gpsbi Smd z oriy Lublin Poland
Elqqoeeml Shq z ok od Szczecin 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
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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