Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Launched by NOVARTIS PHARMACEUTICALS · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called remibrutinib for people living with relapsing multiple sclerosis (RMS) who are currently being treated with ocrelizumab. The main goal is to find out if remibrutinib is effective and safe for patients who switch from ocrelizumab to this new medication, compared to those who continue taking ocrelizumab. The trial is set to begin recruiting participants soon and is open to men and women aged 40 and older who have been diagnosed with RMS and are stable in their condition.

To participate in the trial, candidates must have been treated with ocrelizumab and be considered suitable for switching to remibrutinib by their doctor or based on their preference. Participants will have regular check-ups and may undergo MRI scans to monitor their health. It's important to note that individuals with certain other health conditions, such as primary progressive multiple sclerosis or significant heart issues, may not be eligible to join. Overall, this study aims to explore new options for managing RMS and improve treatment choices for patients.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Male or female 40 years of age or older
• • Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
• • Treated with ocrelizumab according to routine clinical practice and at standard dose
• • Neurologically stable within 30 days
• • Suitable to be switched to remibrutinib based on physician judgement or patient preference
• Key Exclusion Criteria:
• • Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
• • History of clinically significant Central Nervous System disease or neurological disorders
• • History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
• • Active clinically significant systemic bacterial, viral, parasitic or fungal infections
• • Active, chronic disease of the immune system other than MS
• • Severe cardiac disease or significant findings on the ECG
• • Participant who is unable to undergo MRI scans
• • History of life-threatening infusion or injection reaction related to ocrelizumab
• • Other inclusion and exclusion criteria may apply