Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis. (REDIFINE MS)

August 5, 2026 updated by: Matthew Brier, Washington University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is associated with ongoing inflammation within the central nervous system that may contribute to disease progression even when relapses are controlled. Remibrutinib, a Bruton tyrosine kinase (BTK) inhibitor, may affect immune cells involved in this process, but its effects on inflammation within the brain and spinal cord are not fully understood. [REDEFINE_p...2026_clean | Word] This study will evaluate changes in neuroinflammation and immune activity in participants with relapsing MS by combining advanced imaging and biomarker assessments. Measurements of microglial activity using positron emission tomography (PET), cerebrospinal fluid (CSF) analyses, blood-based biomarkers, and magnetic resonance imaging (MRI) will be used to assess changes associated with remibrutinib treatment. [REDEFINE_p...2026_clean | Word] The study will examine whether changes in imaging and fluid biomarkers are associated with measures of disease severity and whether these biomarkers may help predict longer-term clinical outcomes. Results may improve understanding of the biological effects of BTK inhibition in MS and help identify biomarkers that can be used to monitor treatment response and disease progression.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine in St. Louis
        • Principal Investigator:
          • Matthew R Brier, MD, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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 (C

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Participants randomized to remibrutinib in the parent RESHAPE-MS study.
Drug: Remibrutinib
Participants with relapsing multiple sclerosis enrolled in the parent RESHAPE-MS study who are randomized to receive remibrutinib. Participants undergo PET imaging, MRI, blood collection, and cerebrospinal fluid collection as part of REDEFINE-MS.
Cohort 2
Participants randomized to ocrelizumab in the parent RESHAPE-MS study.
Drug: Ocrelizumab (US)
Participants with relapsing multiple sclerosis enrolled in the parent RESHAPE-MS study who are randomized to continue ocrelizumab. Participants undergo PET imaging, MRI, blood collection, and cerebrospinal fluid collection as part of REDEFINE-MS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Microglial Activity Measured by [11C]-DPA-713 PET
Time Frame: Baseline and 6 months after randomization
Change in regional [11C]-DPA-713 PET distribution volume ratio (DVR) from baseline to 6 months, comparing participants receiving remibrutinib with those receiving ocrelizumab.
Baseline and 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Novartis

Investigators

  • Principal Investigator: Matthew R Brier, MD, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 15, 2029

Study Completion (Estimated)

August 29, 2030

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDIFINE MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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