A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovartis Pharmaceuticals
About this trial
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)).
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.
Trial design
Treatments tested in this trial
- Remibrutinib (blinded)
- Placebo
- Remibrutinib (Open label)
Treatment groups
1,275 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov