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.
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Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Recruiting
29.05.2026
Belgium
Recruiting
29.05.2026
Bulgaria
Recruiting
29.05.2026
Croatia
Recruiting
29.05.2026
Czechia
Recruiting
29.05.2026
Denmark
Recruiting
29.05.2026
Estonia
Recruiting
29.05.2026
Finland
Recruiting
29.05.2026
France
Recruiting
29.05.2026
Germany
Recruiting
29.05.2026
Greece
Recruiting
29.05.2026
Hungary
Not yet recruiting
29.05.2026
Italy
Recruiting
29.05.2026
Poland
Recruiting
29.05.2026
Portugal
Recruiting
29.05.2026
Romania
Recruiting
29.05.2026
Slovakia
Recruiting
29.05.2026
Spain
Recruiting
29.05.2026
Sweden
Recruiting
29.05.2026
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.
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