A clinical trial to find out how well LOU064 (remibrutinib) works and how safe it is for people with secondary progressive multiple sclerosis
Key facts
- Where
- Budapest, Budapest III, Budapest IV, Kistarcsa, Pécs és Tatabánya, MagyarországSee the 6 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- 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)?
- Can you have MRI scans (scans that use strong magnets)?
Where in Magyarország
- Budapesti Bajcsy-Zsilinszky Korhaz Es RendelointezetBudapest, MagyarországTaking people
- Clinexpert Kft.Budapest III, MagyarországTaking people
- S-Medicon Kft.Budapest IV, MagyarországTaking people
- Kistarcsai Flor Ferenc KorhazKistarcsa, MagyarországTaking people
- University of PecsPécs, MagyarországTaking people
- Komarom-Esztergom Varmegyei Szent Borbala KorhazTatabánya, MagyarországTaking 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
- Novartis Pharma AG
- Trial code
- EU 2025-521546-23-00
- Record updated
- 2026. július 30.
- Original description
To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSSRead full original descriptionShow less
A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis
To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS
Inclusion: Signed informed consent must be obtained prior to any assessment performed; Male or female participants aged 18-65 (inclusive) at Screening; Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening; Absence of documented clinical relapses in the 24 months before Screening and randomization; EDSS score of 3.0 to 6.0 (inclusive) at Screening; Documented evidence of disability progression in the 12 months before Screening.
Exclusion: Unwilling or unable to undergo MRI scans as per protocol (for example claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)); Use of exclusionary medication prior to Screening/randomization as listed in the protocol; History of clinically significant CNS disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at Screening; Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant’s ability to cooperate and comply with the study procedures; Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML; Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for at least 1 week after stopping study treatment; Significant bleeding risk or coagulation disorders, at Screening.