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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT07225504•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 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 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), 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.
•Use of exclusionary medication prior to Screening/randomization as listed in the protocol.
•Other protocol-defined inclusion/exclusion critria may apply

Locations (44)

Alabama Neurology Associates PC

Birmingham, Alabama, United States

AZ Integrated Neuro and Spine

Phoenix, Arizona, United States

Fullerton Neuro and Headache Ctr

Fullerton, California, United States

Regina Berkovich MD PhD Inc

West Hollywood, California, United States

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Orlando Health Clinical Trials

Orlando, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Axiom Brain Health

Tampa, Florida, United States

Hawaii Pacific Neuroscience LLC

Honolulu, Hawaii, United States

Key Dates

Start Date

November 11, 2025

Primary Completion Date

December 3, 2030

Completion Date

January 2, 2034

Last Updated

March 20, 2026

Enrollment

1,275

ESTIMATED participants

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Interventions

Remibrutinib (blinded)

DRUG

Placebo

DRUG

Remibrutinib (Open label)

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Multiple Sclerosis-Simvastatin Trial 2

NCT03387670

Secondary Progressive Multiple Sclerosis (SPMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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