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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis

Who can join

Ages 18 to 65 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.
* 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.
* Use of exclusionary medication prior to Screening/randomization as listed in the protocol.

Other protocol-defined inclusion/exclusion critria may apply

About the study

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 1,275 · Started: Nov 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07225504

Locations in the U.S.

AlabamaAlabama Neurology Associates PC, Birmingham
ArizonaAZ Integrated Neuro and Spine, Phoenix
Ctr for Neurology and Spine, Phoenix
Center for Neurosciences, Tucson
CaliforniaFullerton Neuro and Headache Ctr, Fullerton
Regina Berkovich MD PhD Inc, West Hollywood
ColoradoUC Health Neuroscience Ctr, Aurora
District of ColumbiaGeorgetown University Hospital, Washington D.C.
Medstar Washington Hosp Ctr, Washington D.C.
FloridaNeurology of Central FL Res Ctr, Altamonte Springs
UF Health Cancer Center, Gainesville
Homestead Assoc In Research Inc, Homestead
Neurology Associates PA, Maitland
Miami NS Ins Baptist Health S FL, Miami
Aqualane Clinical Research, Naples
Comprehensive Neurology Clinic, Orlando
Orlando Health Clinical Trials, Orlando
Neurology Associates of Ormond Beach, Ormond Beach
Axiom Brain Health, Tampa
University Of South Florida, Tampa
GeorgiaJoi Life Wellness Group LLC, Smyrna
HawaiiHawaii Pacific Neuroscience LLC, Honolulu
IllinoisNorthwestern Memorial Hospital, Chicago
KansasUniversity of Kansas Hospital, Kansas City
MarylandMid Atlantic Epilepsy and Sleep Ctr, Bethesda
MassachusettsNeuro Institute of New England P C, Foxborough
Elliot Lewis MS Center, Wellesley
U Mass Memorial Medical Center, Worchester
MichiganMichigan Institute of Neurological, Farmington Hills
New MexicoUniversity of New Mexico Hospital, Albuquerque
South CarolinaPremier Neurology, Greenville
TennesseeNeurology Clinic PC, Cordova
TexasCarum Research, Dallas
Saturn Research Solution, Plano
WashingtonCitta Clinical Research, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.