Efficacy and safety of remibrutinib after switching from ocrelizumab in participants living with relapsing multiple sclerosis, followed by open-label treatment with remibrutinib

Novartis: CLOU064C12306
A randomized, open-label, parallel-group, non-inferiority study comparing efficacy, safety, and tolerability of remibrutinib after switching from ocrelizumab in participants living with relapsing multiple sclerosis, followed by open-label treatment with remibrutinib

medical-cross
Multiple sclerosis
user
All genders
person-wave 40+
world
Recruiting now
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Overview
Principal Investigator: Kristen Babinski, MD, PhD

The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous treatment in RMS. The trial will assess whether remibrutinib could be a safe and effective MS option for sequential use after the use of anti-CD20 therapies like ocrelizumab.

Study details
Inclusion Criteria
  • Male or female 40 or older at screening with a diagnosis of RMS
  • Treated with ocrelizumab for at least 18 months.
  • The last dose of ocrelizumab must have occurred within 5 to 9 months prior to randomization
Exclusion Criteria
  • Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
  • - History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at Screening.
Study Requirements

There will be a core part and an extension part (for eligible participants). The core part (CP) will last a maximum of 24 months and the extension part will last a maximum of 24 months. There will be a total of 14 visits for the CP and 11 visits for the extension part. During the CP, participants will have a total of 11 ECGs, 11 blood draws and 5 MRIs. During the EP, participants will have a total of 7 ECGs, 7 blood draws and 5 MRIs.