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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07758270
Status
Recruiting
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Conditions

  • Multiple Sclerosis (MS) - Relapsing-remitting

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

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.
  • 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 Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Aug 15, 2029
Completion
Aug 29, 2030

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Cohort 1
    Participants randomized to remibrutinib in the parent RESHAPE-MS study.
  • Arm: Cohort 2
    Participants randomized to ocrelizumab in the parent RESHAPE-MS study.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine in St. LouisSt LouisMissouri63110
Nicole Shelley
[email protected]
314-362-7666
Kelley M Jackson, BS
[email protected]
314-362-3613
Matthew R Brier, MD, PhD (PRINCIPAL_INVESTIGATOR)

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