6 trials tracked · 6 active · last refreshed 2026-08-16
Remibrutinib is an experimental pill for multiple sclerosis (MS) that works very differently from the antibody infusions most people think of when they picture MS treatment. It blocks an enzyme called BTK (Bruton's tyrosine kinase) inside certain immune cells, including B cells and the brain's own resident immune cells (microglia). That dials down the inflammatory activity driving MS relapses without wiping out the B cells entirely the way older antibody drugs do, and because it's a small molecule rather than an antibody, it can also get into the brain itself and act on immune cells already living there — something infused antibodies generally can't do as well.
All six active trials are testing where remibrutinib actually fits in MS care. Two large Phase 3 studies pit it directly against teriflunomide, an existing oral MS drug, in relapsing MS. Another Phase 3 trial is testing it specifically in secondary progressive MS, a harder-to-treat, later-stage form of the disease with fewer treatment options. Two smaller studies use brain imaging (MRI, and a dedicated brain-and-immune-changes study) to watch what the drug is actually doing inside the brain during treatment. And notably, one trial is testing what happens when patients switch to remibrutinib after already being on ocrelizumab — today's standard antibody infusion — suggesting it's being positioned as a possible oral step-down option for people who want to move off infusions.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT07758270 | Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis. | N/A | Recruiting | 2026-08-15 |
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. Enrollment 15 (estimated) Sites 1 across 1 country Countries United States Sponsor Washington University School of Medicine Primary outcome: Change in Microglial Activity Measured by [11C]-DPA-713 PET | |||||
| ▸ | NCT07222956 | A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS | Phase II | Not yet recruiting | 2026-06-30 |
The study is an investigator-run, study following participants for 2 years with twice-daily remibrutinib. MRI is the main endpoint. Safety, tolerability, and efficacy are secondary endpoints. Approximately 20 participants with relapsing or progressive forms of MS will be recruited. Enrollment 20 (estimated) Sites 1 across 1 country Countries United States Sponsor Moein Amin Primary outcome: Quantitative MRI volumetric measurements | |||||
| ▸ | NCT07225504 | A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis | Phase III | Recruiting | 2025-11-11 |
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS) Enrollment 1,275 (estimated) Sites 256 across 32 countries Countries Argentina, Australia, Austria, Belgium, Brazil +27 more Sponsor Novartis Pharmaceuticals Primary outcome: Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS) | |||||
| ▸ | NCT06846281 | Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. | Phase III | Recruiting | 2025-06-23 |
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS). Enrollment 360 (estimated) Sites 128 across 19 countries Countries Argentina, Australia, Belgium, Brazil, Canada +14 more Sponsor Novartis Pharmaceuticals Primary outcome: Annualized rate of new or enlarging T2 lesions_Core Part | |||||
| ▸ | NCT05147220 | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) | Phase III | Active, not recruiting | 2021-12-16 |
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Enrollment 1,000 (actual) Sites 199 across 34 countries Countries Argentina, Austria, Belgium, Brazil, Bulgaria +29 more Sponsor Novartis Pharmaceuticals Primary outcome: Annualized relapse rate (ARR) of confirmed relapses [Core Part] | |||||
| ▸ | NCT05156281 | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) | Phase III | Active, not recruiting | 2021-12-13 |
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Enrollment 1,007 (actual) Sites 222 across 27 countries Countries Argentina, Brazil, Bulgaria, Canada, China +22 more Sponsor Novartis Pharmaceuticals Primary outcome: Annualized relapse rate (ARR) of confirmed relapses [Core Part] | |||||
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