Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Remibrutinib
DrugParticipants 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)
DrugParticipants 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Cohort 11 intervention
Group B: Cohort 21 intervention
Trial outcomes
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.
Time frame
Baseline and 6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Novartis
Collaborator
Source ClinicalTrials.gov