A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Key facts
- Where
- Catania, Cefalu', Chieti Scalo, Florence, Messina, Milan, Naples, Orbassano, Pozzilli, and Rome, ItalySee the 11 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?
- In the past 2 years, have you had a relapse (a flare-up of new or worse MS symptoms)?
- Do you have another disease of the immune system, or a long-term infection such as hepatitis B, hepatitis C or HIV?
- Have you ever had cancer?
Source: NCT07299019, 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 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 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
- NCT07299019EU 2025-524322-18-00
- Record updated
- 4 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 non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 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 Non-active Secondary 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 non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.
Inclusion: 18 to 60 years of age, inclusive, at the time of signing the informed consent; Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria; Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013; Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s); Absence of clinical relapses for at least 24 months.
Exclusion: History of suicidal behavior within 6 months prior to Screening; Patients on anticoagulation, or antiplatelet therapy; Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 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 corticosteroid therapy; History or current diagnosis of other neurological disorders that may mimic MS; Active, clinically significant viral, bacterial, or fungal infection; History of any other significant active medical condition; Any prior history of malignancy; Clinically significant laboratory abnormalities at Screening; The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria; History or current diagnosis of progressive multifocal leukoencephalopathy.