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RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well remibrutinib works and how safe it is. It is for adults ages 18–65 with secondary progressive multiple sclerosis (SPMS), a form of MS in which disability gets worse over time.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before any study tests.
  • Be 18–65 years old at screening.
  • Have a diagnosis of MS and currently have SPMS, based on the study’s medical guidelines.
  • Have no recorded MS relapses (flare-ups) in the 24 months before screening and assignment to a study group.
  • Have an EDSS score of 3.0–6.0 at screening. This scale measures disability caused by MS.
  • Have records showing that disability got worse in the 12 months before screening.

Who can't join

  • Be unable or unwilling to have MRI scans, which take pictures inside the body. Reasons may include fear of tight spaces or unsafe metal or devices in the body.
  • Have a history of serious brain or spinal cord disease or injury, or a nerve condition that could look like MS.
  • Have ongoing drug or alcohol abuse, or another issue, such as a serious mental health condition, that could prevent following study steps.
  • Have had confirmed PML, a serious brain infection, or have nerve-related symptoms that suggest PML.
  • Be able to become pregnant but not use highly effective birth control during treatment and for at least 1 week afterward. It must have a failure rate below 1% per year.
  • Have a major risk of bleeding or a blood-clotting disorder at screening.
  • Have used medicines that the study rules do not allow before screening or assignment to a study group.
  • Other study rules may also affect who can join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (43)

AL

AZ

CA

CO

DC

FL

GA

HI

IL

KS

MA

MD

MI

NC

NM

OH

SC

TN

TX

WA