Remibrutinib for secondary progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Alabama Neurology Associates PC
  Birmingham, Alabama, United States Recruiting
• Xenoscience Inc
  Phoenix, Arizona, United States Recruiting
• Ctr for Neurology and Spine
  Phoenix, Arizona, United States Recruiting
• AZ Integrated Neuro and Spine
  Phoenix, Arizona, United States Recruiting
• Center for Neurosciences
  Tucson, Arizona, United States Recruiting
• Fullerton Neuro and Headache Ctr
  Fullerton, California, United States Recruiting

+246 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.