Remodel-2

Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis

medical-cross
Multiple sclerosis
user
All genders
person-wave 18-55
world
Recruiting now
More information  

Overview
Principal Investigator: Kristen Babinski, MD

To demonstrate that remibrutinib is superior to teriflunomide in reducing the frequency of confirmed relapses.

Study details
Inclusion Criteria
  • Male or female participants 18 to 55 years (inclusive) at screening
  • 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 lesions in the 12 months prior to screening
  • EDSS score of 0-5.5 (inclusive) at screening and randomization
Exclusion Criteria
  • Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
  • History of clinically significant Central Nervous System disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at screening
  • Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symtpoms consistent with PML prior to randomization
Study Requirements

There will be a screening visit which will consist of physical exam, medical history, blood collection, EDSS assessment, brain MRI, ECG, and CSSRS. After screening visit, there is a randomization visit where the patient will be randomized and receive drug. After randomization visit, there will be study visits every three months for 30 months. These follow up visits will be similar to the screening and randomization visits, but include patient questionnaires and MS disability assessments. There will a brain MRIs every 6 months. Each study visit will expect to take 2.5 hours.