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Remibrutinib for 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

PHASE3 · Novartis · NCT07225504

This trial will try remibrutinib versus placebo to see if it slows disability progression in adults with secondary progressive multiple sclerosis.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1275 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionsremibrutinib
Locations180 sites (Birmingham, Alabama and 179 other locations)
Trial IDNCT07225504 on ClinicalTrials.gov

What this trial studies

This Phase III, randomized, double-blind, placebo-controlled, multi-center study will enroll about 1,275 people with SPMS and no relapses in the prior 24 months. Participants will be assigned to remibrutinib or matching placebo during an event-driven Core Part, followed by an open-label Extension where all eligible participants can receive remibrutinib. The study uses regular clinical visits and MRI scans to track disability progression, safety, and tolerability. Outcomes will focus on slowing sustained disability progression and monitoring adverse events over the treatment period.

Who should consider this trial

Good fit: Adults aged 18–65 with a diagnosis of SPMS, an EDSS score between 3.0 and 6.0, no documented relapses in the prior 24 months, and documented disability progression in the prior 12 months are the intended participants.

Not a fit: People with recent clinical relapses, other significant CNS diseases that mimic MS, contraindications to MRI, or who fall outside the specified age or EDSS ranges are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, remibrutinib could slow disability progression and reduce ongoing disease activity for people with SPMS.

How similar studies have performed: Bruton tyrosine kinase (BTK) inhibitors like remibrutinib have shown promising signals in relapsing forms of MS in earlier studies, but large Phase III evidence in SPMS is limited, so this is among the first large randomized tests in that population.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 179 other locations

+130 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Secondary Progressive Multiple Sclerosis, MS, Multiple sclerosis, secondary progressive multiple sclerosis, SPMS, remibrutinib, LOU064, adult

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.