Trials / Not Yet Recruiting
Not Yet RecruitingNCT07222956
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Moein Amin · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The study is an investigator-run, open-label Phase 2 study with approximately 24 total months of observation, involving approximately 20 participants with relapsing or progressive forms of MS. Participants will be recruited from the patient populations followed at CCF. All participants will take 100 mg remibrutinib twice daily. They will receive 4 MRIs, blood tests, EKGs, physical exams, and clinical functioning exams periodically to assess safety, tolerability, and efficacy of the study drug. All study activities will be performed at the Cleveland Clinic Mellen Center.
Conditions
- Multiple Sclerosis (MS) - Relapsing-remitting
- Multiple Sclerosis (MS) Secondary Progressive
- Multiple Sclerosis (MS) Primary Progressive
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remibrutinib (Open Label) | 100 mg remibrutinib, twice daily |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2030-10-30
- Completion
- 2030-12-30
- First posted
- 2025-10-30
- Last updated
- 2025-10-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07222956. Inclusion in this directory is not an endorsement.