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Phase , Multiple Sclerosis, remibrutinib, INT-Drug

UCI Specialty Area: Neurology
Principal Investigator: Michael Sy
Official Title: 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
A Study On:
Brain - Neurologic/ Psychologic
Multiple Sclerosis MS

Study Description

The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS.

This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants.

All participants completing the 24-month treatment of the Core Part of the study are eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months.

Eligibility

  1. Male or female 40 years of age or older
  2. Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
  3. Treated with ocrelizumab according to routine clinical practice and at standard dose
  4. Neurologically stable within 30 days
  5. Suitable to be switched to remibrutinib based on physician judgement or patient preference

Key

  1. Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
  2. History of clinically significant Central Nervous System disease or neurological disorders
  3. History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
  4. Active clinically significant systemic bacterial, viral, parasitic or fungal infections
  5. Active, chronic disease of the immune system other than MS
  6. Severe cardiac disease or significant findings on the ECG
  7. Participant who is unable to undergo MRI scans
  8. History of life-threatening infusion or injection reaction related to ocrelizumab

Other inclusion and exclusion criteria may apply

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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