NCT06846281 Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
| NCT ID | NCT06846281 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Relapsing Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-06-23 |
| Primary Completion | 2029-07-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-06-23 with a primary completion date of 2029-07-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06846281 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Relapsing Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06846281 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06846281 currently recruiting?
Yes, NCT06846281 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06846281 trial being conducted?
This trial is being conducted at Scottsdale, United States, Irvine, United States, Washington D.C., United States, Altamonte Springs, United States and 11 additional locations.
Who is sponsoring the NCT06846281 clinical trial?
NCT06846281 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 400 participants.
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