The study focuses on Non-active Secondary Progressive Multiple Sclerosis, a form of multiple sclerosis where the disease has become steadily worse without new relapses. The investigational medication being tested is an oral tablet called Orelabrutinib, which is taken by mouth, and it will be compared with an identical looking placebo tablet.
The purpose of the study is to evaluate whether Orelabrutinib can delay the worsening of disability compared with placebo. Participants will receive the assigned tablet each day for several years and will attend regular clinic visits where their ability to perform everyday tasks is checked and brain scans using MRI are performed to look for new lesions. The study will track how long it takes before a confirmed increase in disability occurs and will record any safety concerns throughout the trial.
1randomization and baseline assessments
after enrollment you will be assigned randomly to receive either orelabrutinib or a matching placebo tablet.
baseline assessments include a physical examination, disability scoring (edss), blood tests, and an mri scan of the brain.
2start of study medication
you will begin taking one 80 mg oral tablet each day.
the tablet is taken by mouth with water, preferably at the same time each day.
the medication will be continued for the duration of the study as directed by the trial team.
3regular clinic visits
you will attend scheduled visits every few months to monitor safety and effectiveness.
at each visit blood samples will be collected, your disability level will be reassessed, and any side effects will be recorded.
4periodic mri scans
you will undergo mri scans of the brain at intervals defined by the study protocol to evaluate new or enlarging t2 lesions.
the scans help determine the impact of the study medication on disease activity.
5assessment of disability progression
your edss score will be measured at each visit to detect any confirmed disability progression.
the primary outcome is the time until a confirmed progression lasting at least 24 weeks.
6final study visit
at the end of the trial you will have a comprehensive evaluation including a final mri scan, blood tests, and disability assessment.
the data collected will be used to compare the effects of orelabrutinib with the placebo.
Who Can Join the Study?
Be between 18 and 60 years old when you sign the consent form.
Have a previous diagnosis of relapsing‑remitting multiple sclerosis (RRMS) that was made using the 2024 McDonald Criteria (a set of guidelines doctors use to confirm MS).
Currently be diagnosed with secondary progressive multiple sclerosis (SPMS) according to the clinical guidelines updated in 2013.
Show documented evidence that your disability has gotten worse over the past 24 months without any new relapses (new attacks of symptoms).
Have had no clinical relapses (no new attacks) for at least 24 months.
Have a brain MRI at screening that shows no gadolinium‑enhancing T1 lesions (no active spots that light up after a contrast injection).
If you have previous MRI scans, they must also show no gadolinium‑enhancing T1 lesions for at least 12 months before screening.
Your EDSS (Expanded Disability Status Scale) score must be between 3.0 and 6.5 at the time of screening, indicating a moderate level of disability.
Who Cannot Join the Study?
Having a type of multiple sclerosis called relapsing‑remitting MS (RRMS)—where symptoms flare up and then improve—or secondary progressive MS (SPMS)—where symptoms gradually get worse over time.
Having any other immune system disorder (a disease that affects the body’s defense system) or any condition that requires treatment with steroids such as pills, IV (intravenous), muscle injections, or joint injections (corticosteroid therapy).
Having a history of, or currently having, another brain or nerve disease that can look like multiple sclerosis (neurological disorders that may mimic MS).
Having any other serious ongoing medical illness (significant active medical condition).
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania
Italy
Diagnostics And Consultation Center Convex Ltd.
Sofia
Bulgaria
Nemocnice Jihlava prispevkova organizace
Jihlava
Czechia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti
Italy
Diagnostic Consultative Center 14 Sofia EOOD
Sofia
Bulgaria
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
Vestre Viken HF
Drammen
Norway
Ospedale San Raffaele S.r.l.
Milan
Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano
Italy
Fakultni Nemocnice Brno
Brno
Czechia
Fakultni Nemocnice Hradec Kralove
Novy Hradec Kralove
Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague
Czechia
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Pozzilli
Italy
Aalborg University Hospital
Aalborg
Denmark
Region Midtjylland
Aarhus
Denmark
Centre Hospitalier Universitaire De Rennes
Rennes
France
University Hospital Olomouc
Olomouc
Czechia
Eginitio Hospital
Athens
Greece
Centre Hospitalier Universitaire De Nimes
Nimes
France
Azienda Ospedaliero-Universitaria Sant Andre
Rome
Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm
Germany
Barmherzige Brueder Trier gGmbH
Trier
Germany
University Hospital Bratislava
Bratislava
Slovakia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Kaunas
Lithuania
Fakultna Nemocnica Trnava
Trnava
Slovakia
Noorderhart
Pelt
Belgium
Region Stockholm – SLSO
Stockholm
Sweden
Neurohk s.r.o.
Chocen
Czechia
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
Krajska Nemocnice T Bati a.s.
Zlin
Czechia
Henry Dunant Hospital Center
Athens
Greece
Irccs Centro Neurolesi Bonino Pulejo
Messina
Italy
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Bad Homburg
Germany
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Presov
Slovakia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Chaidari
Greece
Gemeinschaftspraxis fuer Neurologie Dr. med. W. Blersch und Dr. med. J. Redelstein
Regensburg
Germany
Assistance Publique Hopitaux de Paris
Paris
France
Centre Hospitalier Universitaire De Nantes
Nantes
France
Karolinska Universitetssjukhuset
Huddinge
Sweden
Medical Center Nevrocentrum EOOD
Plovdiv
Bulgaria
KBC Zagreb
Zagreb
Croatia
Clinexpert Kft.
Budapest
Hungary
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Porto
Portugal
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabanya
Hungary
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
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
Poznan
Poland
Novo-Med Zielinski I Wspolnicy Sp. j.
Katowice
Poland
Gornoslaskie Centrum Mwdyczne
Katowice
Poland
Clinic4U OÜ
Tallin
Estonia
Hospital Universitario De Cruces
Barakaldo
Spain
University Clinical Hospital Virgen De La Arrixaca
Murcia
Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Cracow
Poland
Pratia S.A.
Skorzewo
Poland
Hospital Vithas Parque San Antonio
Malaga
Spain
Spitalul Clinic Cai Ferate Constanta
Constanta
Romania
Hospital Alvaro Cunqueiro
Vigo
Spain
Hospital General Universitario Gregorio Maranon
Madrid
Spain
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda
Spain
Hospital Universitario 12 De Octubre
Madrid
Spain
Hospital Del Mar
Barcelona
Spain
Mtz Clinical Research Powered By Pratia
Warsaw
Poland
Centrum Medyczne Hcp Sp. z o.o.
Poznan
Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Nowa Sol
Poland
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz
Poland
Euromedis Sp. z o.o.
Szczecin
Poland
Ma-Lek Clinical Sp. z o.o.
Katowice
Poland
Clinicly Sp. z o.o.
Opole
Poland
Uniklinikum Salzburg
Salzburg
Austria
EMC Instytut Medyczny S.A.
Poznan
Poland
Clinirem Sp. z o.o.
Lublin
Poland
Zana-Med Medical Group Sp. z o.o.
Lublin
Poland
Instytut Naukowo-Badawczy Sp. z o.o.
Lublin
Poland
Spitalul Municipal “Sf. Doctori Cosmasi Damian” Radauti
Romania
Cnfm Dp Nzjud
Vandoeuvre Les Nancy
France
Kqpadgnj Btjtehmx Ghws
Bayreuth
Germany
Cwbazt Hjqrnhpeuzf Urcudbxopwcgj Rmhwo
Reims
France
Uvoqyklmulsabnvcxyede Efqtg Alu
Essen
Germany
Nhwrfxgcj Mgbavtkw Skxexlgr Ccdsogp Vwktqw
Steenokkerzeel
Belgium
Smrbomrmx Kubz
Budapest
Hungary
Nwcnpk Snz z okks
Rzeszow
Poland
Htuixsxh Stdeq Cjifbjgg Imo
Salt
Spain
Uptaudcvxscie Slwzhtw Kgcxtuqjj W Oyjizwjxr
Olsztyn
Poland
Hlvgbrwd Ukqxgcpgesaou dg A Ckajaq
A Coruna Galicia
Spain
Hioilkok Uhwstheocqbpq Hfptotws Tdhop y Pstiss Inovhtwd Coikno dbdhiehfojmaijweq (fzik
Badalona
Spain
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Not yet recruiting
16.06.2026
Belgium
Not yet recruiting
16.06.2026
Bulgaria
Not yet recruiting
16.06.2026
Croatia
Not yet recruiting
16.06.2026
Czechia
Not yet recruiting
16.06.2026
Denmark
Not yet recruiting
16.06.2026
Estonia
Not yet recruiting
16.06.2026
France
Not yet recruiting
16.06.2026
Germany
Not yet recruiting
16.06.2026
Greece
Not yet recruiting
16.06.2026
Hungary
Not yet recruiting
16.06.2026
Italy
Not yet recruiting
16.06.2026
Lithuania
Not yet recruiting
16.06.2026
Norway
Not yet recruiting
16.06.2026
Poland
Not yet recruiting
16.06.2026
Portugal
Not yet recruiting
16.06.2026
Romania
Not yet recruiting
16.06.2026
Slovakia
Not yet recruiting
16.06.2026
Spain
Not yet recruiting
16.06.2026
Sweden
Not yet recruiting
16.06.2026
The Netherlands
Not yet recruiting
16.06.2026
Trial locations
Orelabrutinib is an oral tablet that is being tested to see if it can slow down the worsening of disability in people with non‑active secondary progressive multiple sclerosis. In the study, participants take this medication by mouth, and researchers compare their health outcomes to those of participants who receive a placebo. The goal is to find out whether orelabrutinib can help delay the progression of the disease and improve patients’ quality of life.
Secondary progressive multiple sclerosis (non‑active) – It is a stage of multiple sclerosis that follows an earlier relapsing phase and is marked by a steady worsening of disability without new inflammatory attacks. The disease slowly damages the protective coating of nerve fibers, causing slower transmission of nerve signals. Over time, individuals may notice increasing weakness, balance problems, and fatigue. The progression is continuous and is tracked by gradual changes in disability scores.
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