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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509275-17-00
Acronym
CLOU064C12306
Enrollment
158
Registered
2025-08-01
Start date
2025-10-06
Completion date
Unknown
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing multiple sclerosis

Brief summary

Annualized rate of new or enlarging T2 lesions (AR-NELT2) on MRI at Month 24 (relative to baseline MRI scan).

Detailed description

Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI between baseline and Month 24., Adverse events, laboratory data, vital signs, electrocardiograms (ECGs), (Commercially confidential information)., Extension Part: Adverse events, laboratory data, vital signs, electrocardiogram (ECG), (Commercially confidential information)., Extension Part: - Annualized rate of new or enlarging T2 lesions on MRI - Participants with NEDA-3.

Interventions

DRUGOCRELIZUMAB
DRUGLOU064

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Annualized rate of new or enlarging T2 lesions (AR-NELT2) on MRI at Month 24 (relative to baseline MRI scan).

Secondary

MeasureTime frame
Participants with no evidence of disease activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6-month confirmed disability progression (6mCDP) and new/enlarging T2 lesions on MRI between baseline and Month 24., Adverse events, laboratory data, vital signs, electrocardiograms (ECGs), (Commercially confidential information)., Extension Part: Adverse events, laboratory data, vital signs, electrocardiogram (ECG), (Commercially confidential information)., Extension Part: - Annualized rate of new or enlarging T2 lesions on MRI - Participants with NEDA-3.

Countries

Belgium, Denmark, France, Greece, Italy, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026