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Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.

REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)

Who can join

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

Age
40 Years to 70 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

REDEFINE-MS studies how remibrutinib changes immune activity and swelling in the brain and spinal cord in people with relapsing multiple sclerosis (MS) who are in the RESHAPE-MS trial. It uses PET and MRI scans, blood samples, and samples of fluid around the brain and spinal cord before treatment and six months later. Researchers want to learn whether these changes may help predict how MS progresses and how well treatment works.

REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial. The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later. \[REDEFINE\_p...2026\_clean \| Word\] The main question the study is trying to answer is whether remibrutinib changes immune activity and inflammation in people with MS, and whether these changes can be measured using imaging and biological markers that may help predict future disease progression and treatment response.

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

Eligibility

Who can join

  • Can give written consent to take part in research procedures.
  • Any sex or race.
  • Are 40 to 70 years old.
  • Have relapsing MS based on the study’s required diagnosis rules.
  • Have a score of 0 to 6.5 on the EDSS, a scale that measures disability from MS.
  • Have received standard-dose ocrelizumab as usual care for at least 18 months. The last dose must be 5 to 9 months before being assigned to a treatment group.
  • Have had stable nerve and brain symptoms, with no MS relapse, during the 30 days before screening.
  • Are suitable to switch to remibrutinib based on the doctor’s judgment or your preference.

Who can't join

  • Meet any exclusion rule from the parent study. Those rules are not listed here.
  • Are allergic to [11C]-DPA-713, the substance used for PET imaging, or any of its ingredients.
  • Cannot safely have PET or MRI scans, for example because of certain medical devices or trouble lying still for a long time.
  • Have a TSPO gene variation that causes the imaging substance to bind poorly.
  • Have a condition that the study doctor thinks could make participation unsafe or difficult, such as liver or kidney disease or advanced cancer.
  • Are in, or were in during the past 12 months, research using radioactive substances that would put your total yearly research radiation exposure above U.S. legal limits.

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

Official eligibility criteria

Inclusion Criteria * Capable of providing written informed consent for volunteering to undergo research procedures. * Male or female, any race * Age between 40 and 70 years of age, inclusive * Diagnosis of RMS according to revised 2017 McDonald criteria at screening 15 * EDSS score of 0 to 6.5 (inclusive) at screening * Treated with ocrelizumab according to routine clinical practice and at standard dose for at least 18 months. The last administration of ocrelizumab must have occurred within 5 to 9 months prior to randomization. * Neurologically stable within 30 days prior to screening, including no MS relapse during this period. * Suitable to be switched to remibrutinib based on physician judgement or patient preference. Exclusion Criteria: The exclusion criteria of the parent study are adapted and inherited under this section (See parent study protocol section 5.2). In addition, the following exclusion criteria apply: * Hypersensitivity to \[11C\]-DPA-713 or any of its excipients * Contraindications to PET or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate * Presence of a low affinity binding TSPO polymorphism. * Any condition that, in the opinion of the Principal Investigator or his designee, could increase the risk to the participant or limits their ability to participate (e.g., liver or kidney disease, advanced cancer) * Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1.

Study sites (1)

MO