Last Update: Dec 15, 2025
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLOU064P12301
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Secondary Progressive Multiple Sclerosis (SPMS)
Phase3
Recruiting
1275
Nov 11, 2025
Jan 02, 2034
All
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug

Placebo

Matching placebo (binded), oral tablet
Drug

Remibrutinib (blinded)

Remibrutinib (Blinded) active treatment, oral tablet
Drug

Remibrutinib (Open label)

Remibrutinib (Open Label), oral tablet

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 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

Novartis Investigative Site

Recruiting

Kogarah,New South Wales,2217,Australia

Novartis Investigative Site

Recruiting

Lévis,Quebec,G6w 0m5,Canada

Novartis Investigative Site

Recruiting

Rehovot,7661041,Israel

Novartis Investigative Site

Recruiting

Ẕerifin,7030000,Israel

AZ Integrated Neuro and Spine

Recruiting

Phoenix,Arizona,85037,United States

Barry Hendin
Brandon McCravey

Neurology Associates of Ormond Beach

Recruiting

Ormond Beach,Florida,32174,United States

Heather Schutz
James Scott

Neurology Clinic PC

Recruiting

Cordova,Tennessee,38018,United States

Lee Stein
Ye Liu

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals