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Clinical Trials in the UK / NCT07225504
Recruiting Phase 3

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

NCT07225504 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2025-11-11
Last updated
2026-07-29

Condition(s) studied

Secondary Progressive Multiple Sclerosis (SPMS)

Investigational drug(s) / intervention(s)

Remibrutinib (blinded)PlaceboRemibrutinib (Open label)

Remibrutinib (blinded): Remibrutinib (Blinded) active treatment, oral tablet

Placebo: Matching placebo (binded), oral tablet

Remibrutinib (Open label): Remibrutinib (Open Label), oral tablet

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (256)

FacilityCityRegionStatus
Alabama Neurology Associates PC Birmingham Alabama Recruiting
Ctr for Neurology and Spine Phoenix Arizona Recruiting
AZ Integrated Neuro and Spine Phoenix Arizona Recruiting
Center for Neurosciences Tucson Arizona Recruiting
Fullerton Neuro and Headache Ctr Fullerton California Recruiting
Regina Berkovich MD PhD Inc West Hollywood California Recruiting
UC Health Neuroscience Ctr Aurora Colorado Recruiting
Georgetown University Hospital Washington D.C. District of Columbia Recruiting
Medstar Washington Hosp Ctr Washington D.C. District of Columbia Recruiting
Neurology of Central FL Res Ctr Altamonte Springs Florida Recruiting
UF Health Cancer Center Gainesville Florida Recruiting
Homestead Assoc In Research Inc Homestead Florida Recruiting
Neurology Associates PA Maitland Florida Recruiting
Miami NS Ins Baptist Health S FL Miami Florida Recruiting
Aqualane Clinical Research Naples Florida Recruiting
Orlando Health Clinical Trials Orlando Florida Recruiting
Comprehensive Neurology Clinic Orlando Florida Recruiting
Neurology Associates of Ormond Beach Ormond Beach Florida Recruiting
Axiom Brain Health Tampa Florida Recruiting
University Of South Florida Tampa Florida Recruiting
Joi Life Wellness Group LLC Smyrna Georgia Recruiting
Hawaii Pacific Neuroscience LLC Honolulu Hawaii Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
University of Kansas Hospital Kansas City Kansas Recruiting
Mid Atlantic Epilepsy and Sleep Ctr Bethesda Maryland Recruiting
Neuro Institute of New England P C Foxborough Massachusetts Recruiting
Elliot Lewis MS Center Wellesley Massachusetts Recruiting
U Mass Memorial Medical Center Worchester Massachusetts Recruiting
Michigan Institute of Neurological Farmington Hills Michigan Recruiting
University of New Mexico Hospital Albuquerque New Mexico Recruiting
Premier Neurology Greenville South Carolina Recruiting
Neurology Clinic PC Cordova Tennessee Recruiting
Carum Research Dallas Texas Recruiting
Saturn Research Solution Plano Texas Recruiting
Citta Clinical Research Spokane Washington Recruiting
Novartis Investigative Site CABA Buenos Aires Recruiting
Novartis Investigative Site Capital Federal Buenos Aires Recruiting
Novartis Investigative Site Buenos Aires Buenos Aires F.D. Recruiting
Novartis Investigative Site Bombal Mendoza Province Recruiting
Novartis Investigative Site San Juan San Juan Province Recruiting

+ 216 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07225504 on ClinicalTrials.gov ↗ ← All trials in the UK