Tests orelabrutinib against placebo in secondary progressive multiple sclerosis
Tests orelabrutinib, compared with placebo, in adults with non-active secondary progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Key facts
- Where
- Bydgoszcz, Cracow, Gdansk, Katowice, Lodz, Łódź, Lublin, Nowa Sol, Olsztyn, Plewiska, Poznan, Rzeszów, Szczecin, Warsaw, and Zory, PolandSee the 28 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 Poland
- Centrum Medyczne INTERCOR Sp. z o.o.Bydgoszcz, PolandTaking people
- Linden Sp. z o.o. sp.k.Cracow, PolandTaking people
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.Cracow, PolandTaking people
- Copernicus Podmiot Leczniczy Sp. z o.oGdansk, PolandTaking people
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
- MA-LEK Clinical Sp. z o.o.Katowice, PolandTaking people
- NEURO-MEDIC Sp. z o. o.Katowice, PolandTaking people
- Novo-Med Zielinski I Wspolnicy Sp. j.Katowice, PolandTaking people
- Pratia S.A.Katowice, PolandTaking people
- Clinicly Sp. z o.o.Lodz, PolandTaking people
- Centrum Neurologii Krzysztof SelmajŁódź, PolandTaking people
- Clinirem Sp. z o.o.Lublin, PolandTaking people
- Instytut Naukowo-Badawczy Sp. z o.o.Lublin, PolandTaking people
- Malva Trials Sp. z o.o.Lublin, PolandTaking people
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.Lublin, PolandTaking people
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.Nowa Sol, PolandTaking people
- Uniwersytecki Szpital Kliniczny W OlsztynieOlsztyn, PolandTaking people
- Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki HertmanowskiejPlewiska, PolandTaking people
- Centrum Medyczne HCP Sp. z o.o.Poznan, PolandTaking people
- EMC Instytut Medyczny S.A.Poznan, PolandTaking people
- Ilkowski I Partnerzy sp.p. LekarzyPoznan, PolandTaking people
- Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.Poznan, PolandTaking people
- Nmedis sp. z o.o.Rzeszów, PolandTaking people
- EUROMEDIS Sp z o oSzczecin, PolandTaking people
- Instytut Psychiatrii I NeurologiiWarsaw, PolandTaking people
- MTZ Clinical Research powered by PratiaWarsaw, PolandTaking people
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Neurokard Sp. z o.o.Zory, PolandTaking 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.