Recruiting

Remibrutinib

Sponsor:

Washington University School of Medicine

Code:

NCT07758270

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Remibrutinib

Ocrelizumab (US)

Study Details

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

Study ID

NCT07758270

Start date

Aug 15, 2026

Status verified date

Aug, 2026

Completion date

Aug 29, 2030

Anticipated

Primary completion date

Aug 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

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

Cohort 2

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

Interventions

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.

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.

Primary outcome measure

  • Change in Microglial Activity Measured by [11C]-DPA-713 PET [ Time Frame: Baseline and 6 months after randomization ]

Central Contacts and Locations

Central contacts

Nicole Shelley

314-362-7666nshelley@wustl.edu

Kelley M Jackson, BS

314-362-3613kelleyj@wustl.edu

Locations

Washington University School of Medicine in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Nicole Shelley

314-362-7666nshelley@wustl.edu

Kelley M Jackson, BS

314-362-3613kelleyj@wustl.edu

Principal Investigator:

Matthew R Brier, MD, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Multiple Sclerosis, Relapsing Multiple Sclerosis and Neuroinflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-11.