Remibrutinib after switching from ocrelizumab for relapsing multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, phase 3b non-inferiority study randomizes people with relapsing MS who are being treated with ocrelizumab to either switch to oral remibrutinib or continue standard-dose ocrelizumab. The Core Part follows participants for up to 24 months to collect efficacy, safety and tolerability data, and eligible participants may join a 24-month open-label extension where all receive remibrutinib. Key inclusion criteria include age 40–70, a relapsing MS diagnosis by 2017 McDonald criteria, neurological stability, and suitability to switch from ocrelizumab, while key exclusions include primary progressive MS, active serious infections, prior PML, major immune or cardiac comorbidities, or inability to undergo MRI. The trial is conducted at multiple centers globally, including sites in the United States, and is sponsored by Novartis.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Male or female aged 40 to 70 years (inclusive)
* 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
* Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)

Other inclusion and exclusion criteria may apply

Where it's running

• Perseverance Research Center
  Scottsdale, Arizona, United States Recruiting
• University of California Irvine
  Irvine, California, United States Recruiting
• Medstar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Neurology of Central FL Res Ctr
  Altamonte Springs, Florida, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Memorial Healthcare System
  Hollywood, Florida, United States Recruiting

+81 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.