A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Key facts
- Where
- Catania, Cefalu', Chieti Scalo, Florence, Genoa, Messina, Milan, Naples, Orbassano, Pozzilli, and Rome, ItalySee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
- Which type of multiple sclerosis (MS) has your doctor told you that you have?
Source: NCT07067463, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Fondazione Istituto G. Giglio Di CafaluCefalu', ItalyTaking people
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- IRCCS Centro Neurolesi Bonino PulejoMessina, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zenas BioPharma (USA), LLC
- Trial code
- NCT07067463EU 2025-524316-11-00
- Record updated
- 10 November 2026
- Original description
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Inclusion: 18 to 60 years of age, inclusive; Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria; Participant must have documented evidence of disability progression observed during the 24 months before screening; Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.
Exclusion: History of suicidal behavior within 6 months prior to Screening; Patients on anticoagulation, or antiplatelet therapy will be excluded; Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days; Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening; History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening; Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy; History or current diagnosis of other neurological disorders that may mimic MS; History of any other significant active medical condition; Any prior history of malignancy if no recurrence within 5 years; Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention; Clinically significant laboratory abnormalities at Screening; Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS).