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

NCT07758270 | Recruiting FDA Drug

• 1 other identifier: REDIFINE MS
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

Multiple Sclerosis, Relapsing Multiple Sclerosis and Neuroinflammation

Outcome Measures

Primary Outcomes (1)

• Change in Microglial Activity Measured by [11C]-DPA-713 PET

  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

Study Arms (2)

Cohort 1

Participants randomized to remibrutinib in the parent RESHAPE-MS study.

Drug: Remibrutinib

Cohort 2

Participants randomized to ocrelizumab in the parent RESHAPE-MS study.

Drug: Ocrelizumab (US)

Interventions

Remibrutinib DRUG

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 1

Ocrelizumab (US) DRUG

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.

Cohort 2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Novartis: collaborator

Study Sites (1)

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebrospinal fluid (CSF), DNA, and other processed biospecimens will be stored for future research. Samples may be used for future analyses, including genetic testing and research related to multiple sclerosis, neuroinflammatory and neurodegenerative disorders, and other scientific investigations. De-identified specimens and associated data may be shared with qualified researchers and approved research repositories

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Neuroinflammatory Diseases

Interventions

remibrutinib; ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew R Brier, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Shelley

CONTACT

314-362-7666; nshelley@wustl.edu

Kelley M Jackson, BS

CONTACT

314-362-3613; kelleyj@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 29, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

US (1)