Type of MS: RRMS|SPMS
Treatment mode of action: To affect immune function
Number of Subjects: 5
Medication: remibrutinib vs. teriflunomide
Institutions: Nova Clinical Research
2010 59th St West
Bradenton Florida 34209 Suite 3800
Please see below.
Remibrutinib inhibits an enzyme called “Bruton’s tyrosine kinase,” reducing the activation of B cells, which are immune cells that play a role in the response that affects the brain and spinal cord in MS.
This study is for participants diagnosed with relapsing multiple sclerosis and will be given either Remibrutinib twice a day or Teriflunomide once a day for 30 months. There will be a total of 12 visits and each one every 3 months. Among the office visit tests and labs to be performed include (but not limited to) blood draws with blood coagulation panel and urine samples. MRI scan will be performed on eligible participants. Physical examination and medical history, vital signs, electrocardiogram, pregnancy test (if applicable) will be performed throughout the study. Subjects will require to keep a daily diary at home to note the medication was taken daily and on time, any other medication taken prescribed and over the counter.
Inclusion Criteria to be in the study:
- Age 18-55 at the time screening
- Diagnosis of RMS (this includes relapsing-remitting course (RRMS) or secondary progressive (SPMS) course with disease activity)
- At least: 1 documented relapse within the previous year, OR 2 documented relapses within the previous 2 years, prior to screening, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months prior to screening
- Neurologically stable within 1 month prior to screening and randomization (including no MS relapse in this period)
Possibility of compensation for travel to the office visits.
Further criteria are available from the study contacts:
Stephanie Quezada, MD and Dena O’York, RN