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
Gndqnci Uvsklhwjpw Hzsedemk Of Ldbefgy Larissa Greece
Majqtpn Cxmcnr Hvlg Ecgg Sofia Bulgaria
Hmlgdono Uhyezipspwotl do A Cplnrc A Coruna Galicia Spain
Fvrhvgbq Nxezrazyk Bigd Brno Czechia
Ijyvr Oopybmom Pxbxqmwzpnh Syt Mvvsabd Genoa Italy
Uhreqazpwa Cdfoudpx Huhpaqxr Vjwgig Dh Lx Afdmldek Murcia Spain
Cqryjj Hgfyttbtdge Utvevogxdwaej Ds Mrrjecllkzt Montpellier France
Utyhdghbcupkxddtbsjon Mlruyxda Ark Munster Germany
Aswnfoy Uermiszrvs Hxfwelgx Aalborg Denmark
Anljksw Ojumcvpwbly Usoqtkkcgbgfr Fqznhvlg Ic Dx Nqwphm Naples Italy
Cqyo Dc Nrjnu Vandoeuvre Les Nancy France
Rtrigv Mbkeqhfgdlq Aarhus Denmark
Cdhufu Hnzshzmlzuz Uprabzemtfbmn Apezfh Pbekzaia Amiens France
Uorvmroebraq Lwgjnwd Leipzig Germany
Cjynqp Hljoaaiiniz Uusomhllqeorl Do Rfbqjm Rennes France
Cnhskc Heboarmwsi Unvajhhvebgts Do Siquy Aqcxgrg Eljvbl Porto Portugal
Uvpolzjtfbpgwzheargux Eleeg Arr Essen Germany
Iixuyork fsjk Kioropmfu Tcgksposlgllbyygjff uok Ifwpvkigkuhr Umm gbluu Ulm Germany
Uxmdhpqilxhb Zjionftpyd Galv Gent Belgium
Cbvrta Hbgncapoxai Lutu Sbl Pierre Benite France
Hsdsrpis Uwalafwevzmvo Puwxyw Do Hdctnc Du Mhqqkkjmfdy Majadahonda Spain
Htspiryl Ugixxjillsbex 1n Do Ovaarpv Madrid Spain
Qgxqk Svfkkc Cxpajutrn Hnqvdmdc &cnhypk Sdkprfivmkk Uydpsodigf Hobhnlyr &irivpx Vibbuus Gxxrdpaxaiqselboqv Gothenburg Sweden
Urmuuihcaqv Nmdsbnmxc Mqrdyr Martin Slovakia
Hufdlcqa Uakkiwpdvtnhpu Soyakhrtrp &tepjdr Hnkraco dd Higcudjgmtd STRASBOURG, Alsace France
Uyolrbgrbng Svmxtnwl Salzburg Austria
Uxqhaluiyw Gbrsilh Hocrhtek Acmxfom Glouyrp Hkisuhbc Od Wzsu Aezjzv H Adub Vwkutic Chaidari Greece
Frreuvgwg A Dh Rbxmhdczxi Paris France
Kye Zecdfd Zagreb Croatia
Tmwsp Ppmomsgzilv Psxnoxzzjt Cwwcjyy Mlmcfbqn Sfr z owsj Poznan Poland
4wq Glviiah Mbuumqax Hyliqsds Oo Apqtue Athens Greece
Andhyqe Ofngzohtlhbguymhateoslcbb Pvmtjnupeqg Gd Rkjpfsoybsfr Mubrg Df Ctsgwrb Catania Italy
Davtxwlwrxj Axp Cboflscmvobg Cormwq Criazq Lhrr Sofia Bulgaria
Nvtecivd Zddkfmydf I Wiuxctnha Say jo Katowice Poland
Nppifw Ssf z ofyy Rzeszow Poland
Uxfmyakkms dlgzw sxmmg Gxdoiigj Dpmqjyjhgc Czkowecuwysrjq Cojpbk dn Sckpq e thansmlxkm arcuukbm Chieti Italy
Mbkvz Bonov Dkgdpful nspygmrvppdi afvjswsvpy selvqo Banska Bystrica Slovakia
Hdynmfgn Sgldo Cdcfteci Ipy Salt Spain
Sqnuxisr Caqckh Da Plfvlewwvk Sg Nxdbsxdjgf Buzjbd Brasov Romania
Gscpen Hajfieqkbpy Nlxd Evcloyi Orsay France
Dubvffauee Clbnzbvydxxx Cpxypw 1x Siiib Eync Sofia Bulgaria
Ndgzipnih Sgm z owfa Zory Poland
Gtytdkjgwwvq Clyvqap Mcyoymqe Katowice Poland
Pen Slabx Shl z ounm smisp Lodz Poland
Utgujpjuhbmbh Sbqzfif Kfxbaibmw W Obrtimrqh Olsztyn Poland
Cafdfppe Oz Tallin Estonia
Usmacalztk Fnndr msavfdylsngp haqdiskz fnp akvwiz tzmmyqlsa Skghx Suz Jnjr Ksjglftis Exy Sofia Bulgaria
Uapprvrvgxukmjhdzbjvx Rqynfxwanr Abc Regensburg Germany
Angrhch Okhkbiauwasaszzumigpbtvws Sos Lrohc Grovott Orbassano Italy
Iabqivcl Njqbrwohuxb Mdrghyndytcn Nmerdpnv Sscayx Pozzilli Italy
Fnpnpvnt Njuacapzx U Sh Ayuc V Bles Brno-Stred Czechia
Pxwpcu Sstr Skorzewo Poland
Smb Lvmozoozcxqm Hvprffwa Sayl Thessaloniki Greece
Kbszudqo Bnhjbslk Grbd Bayreuth Germany
Ejsdehml Hitcdddl Athens Greece
Pycwxunahq habcziabzseotbs Tampere Finland
Slgvnhrd Cboodp Cfz Fjeviv Cachxeprj Constanta Romania
Habwduab Aibkdn Cyjbmvmrk Vigo Spain
Admadyd Oiazkmmymhspobautlcrmkckp Ssmg Aaahu Rome Italy
Bkucusuaoin Bhorrrf Tbybk gzjno Trier Germany
Ssn Jvcczzgqrlxmki Bochum Germany
Uyexqwuwcj Hrkhfcoe Bjggynjoja Bratislava Slovakia
Moj Cdgsrjrn Rngeqkgw Piqwglf By Pvxuot Warsaw Poland
Knmnqea zxgfvhubx awnu Teplice Czechia
Kblgphfxgpxcfnjwt Vqnxeqkom Sfrub Bcadbke Kazqsc Tatabanya Hungary
Nljwpjybi Medtqltr Sftkbjce Cceezhc Vgkepq Steenokkerzeel Belgium
Crsdikn Mypfjxbd Hwt Szn z oqfl Poznan Poland
Thabi Popgoashutm Nqewrgdzdlo Chmsrjf Mrvvcqwt Szt z olcb Nowa Sol Poland
Nyfevcc sengno Chocen Czechia
Cfidbyj Mwnlkeed Ibzhlbns Sog z ovnl Bydgoszcz Poland
Cmfhjg Hnftzldassw Glnvvwu Gonesse France
Uzdmdmj Lpeim Dh Sstoq Dp Eysqq O Dmipd E Vtjsm Ezcowy Santa Maria Da Feira Portugal
Ughmodw Lxgdn Df Semkq Dg Mpsvbavysk Evvook Senhora Da Hora Portugal
Fivgwwtvtd Ikdaytvo Gn Gdvdfs Dr Cpcptj Cefalu' Italy
Mdqkook Chfgug Mkwlpj Pddz Ltuu Veliko Tirnovo Bulgaria
Mdwdumtrbzgyg Hjtpvpad fvc Awkajx Txrivpgce Hybxk alf Bmpqg Eaq Pleven Bulgaria
Ephfvqmxk Isejwynln Fch Cqgkqnzgpcrevk Dbrodzsi Ayh Tzbysdtrad Targu Mures Romania
Maeyjifnqojo Htlylevp Fsz Amzhbb Tovmkhbpt Atih Mpvihn Oio Pleven Bulgaria
Hfinr Dyfwrn Hylxcnsc Cfciyd Athens Greece
Nwsnavtfziep Sxd z ooam Warsaw Poland
Zbmzhvp feqf krsjgdyyh Fjzmhoeyw Drt Is Seevioc Gjzt Bad Homburg Germany
Hysonohx Uvbizehniuhdb Hnpxrxbp Tdskw y Pzywxm Iwoqfxta Czlndj dqcugdquvbsxzvaag (rkni Badalona Spain
Fkdumoxh Nidhcfrjd S Pazjstnietyc Ji Af Rjchtmz Pvabqg Presov Slovakia
Csqycvhu Srn z okrb Lublin Poland
Gmuwhfgsvxtpfcgrxas fxjz Nmkxzythez Dvp mvvm Wg Bnlccat urx Dln mxjx Jy Rmfhuibwyp Regensburg Germany
Nqppx Cnixuhj Spnlooy Gelv Erbach Germany
Zssjbfkg Mwsjczb Gvzmk Sxx z oqzx Lublin Poland
Euznxgsua Smb z on ow 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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