IRB Study Number 26-437
Status Recruiting
Phase Phase 3
Location U Building - Mellen Center
Institute Neurological Institute
Description
The purpose of this study is to see how well remibrutinib works and how safe it is compared to placebo in people with secondary progressive multiple sclerosis (SPMS).
Remibrutinib is an investigational (experimental) drug, which means it has not been approved by the FDA. It works by blocking a molecule called "Bruton's tyrosine kinase (BTK)" in the blood and brain. by targeting BTK, remibrutinib may help slow disease progression and reduce development of new brain lesions.
The duration of the core part of the study is roughly 5 years. There are up to 11 visits to the trial site (4 of these are for collection of LFTs and may be conducted offsite). There is also the potential for a 3 year open-label extension.
Activities include study drug administration (oral tablet BID), blood/urine sample collection, neurological and physical exams, questionnaires, and MRI imaging.
Inclusion Criteria
- 18-65 years of age
- Diagnosis of SPMS
- Absence of documented clinical relapses in past 24 months
- EDSS score of 3.0 to 6.0 (inclusive)
- Documented evidence of disability progression in past 12 months
Exclusion Criteria
- Unwilling or unable to undergo MRI scans
- History of clinically significant central nervous system (CNS) disease
- Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere
- History of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML
- Significant bleeding risk or coagulation disorders
- Use of exclusionary medication as listed in protocol
