Multiple Sclerosis (MS) - Relapsing-remittingREDIFINE MSNCT07758270
Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.
An observational study of Multiple Sclerosis (MS) - Relapsing-remitting, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Remibrutinib and Ocrelizumab (US)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 29 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Nicole Shelley, 314-362-7666, nshelley@wustl.edu
Kelley M Jackson, BS, 314-362-3613, kelleyj@wustl.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Remibrutinib, Ocrelizumab (US)
- Keywords
- Multiple Sclerosis, Relapsing Multiple Sclerosis and Neuroinflammation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants randomized to remibrutinib in the parent RESHAPE-MS study. Receives: Drug: Remibrutinib | |
| Cohort 2 | Participants randomized to ocrelizumab in the parent RESHAPE-MS study. Receives: Drug: Ocrelizumab (US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2029 (estimated)
- Study completion29 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Matthew Brier, Washington University School of Medicine
- Investigators
- Matthew R Brier, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758270
- Sponsor's protocol ID
- REDIFINE MS
- Acronym
- REDIFINE MS
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)
- ClinicalTrials.gov ID
- NCT07758270
- Acronym / sponsor ID
- REDIFINE MS / REDIFINE MS
- Keywords
- Multiple Sclerosis, Relapsing Multiple Sclerosis and Neuroinflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 29 Aug 2030 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: RemibrutinibParticipants randomized to remibrutinib in the parent RESHAPE-MS study. |
| Cohort 2 | – | Drug: Ocrelizumab (US)Participants randomized to ocrelizumab in the parent RESHAPE-MS study. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemibrutinibParticipants 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. | Drug | Cohort 1 |
| 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. | Drug | Cohort 2 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew R Brier, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS) - Relapsing-remitting, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Shelley (314-362-7666, nshelley@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Microglial Activity Measured by [11C]-DPA-713 PET (time frame: Baseline and 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.