Status:

RECRUITING

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief 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. ...

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

Key Trial Info

Start Date :

November 11 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 2 2034

Estimated Enrollment :

1275 Patients enrolled

Trial Details

Trial ID

NCT07225504

Start Date

November 11 2025

End Date

January 2 2034

Last Update

April 6 2026

Active Locations (90)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 23 (90 locations)

1

Alabama Neurology Associates PC

Birmingham, Alabama, United States, 35209

2

AZ Integrated Neuro and Spine

Phoenix, Arizona, United States, 85037

3

Center for Neurosciences

Tucson, Arizona, United States, 85718

4

Fullerton Neuro and Headache Ctr

Fullerton, California, United States, 92835

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