Tests remibrutinib in people with secondary progressive multiple sclerosis
Tests remibrutinib against placebo in adults with secondary progressive multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Key facts
- Where
- Bonheiden, Brussels, Leuven, and Roeselare, BelgiumSee the 4 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 65 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)?
- Can you have MRI scans (scans that use strong magnets)?
Source: NCT07225504, who can take part
Where in Belgium
- BonheidenBonheiden, BelgiumTaking people
- BrusselsBrussels, BelgiumTaking people
- LeuvenLeuven, BelgiumTaking people
- RoeselareRoeselare, BelgiumTaking 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 Pharmaceuticals
- Trial code
- NCT07225504
- Record updated
- 13 October 2026
- Original description
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)Read 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
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Inclusion: Signed informed consent must be obtained prior to any assessment performed; Male or female participants aged 18-65 (inclusive) at Screening; Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) 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; Other protocol-defined inclusion/exclusion critria may apply; History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS); 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), 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.