Relapsing Multiple Sclerosis
Conditions
Keywords
MS, RMS, Remibrutinib, LOU064, Ocrelizumab, Age, MRI, T2 lesions, NEDA-3
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).
Detailed 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 may be 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. The study will be conducted in the USA among other countries globally.
Interventions
DRUGRemibrutinib oral treatment
Remibrutinib tablet taken daily
DRUGOcrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of new or enlarging T2 lesions_Core Part | Baseline up to month 24 | Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants with no evidence of disease activity-3 (NEDA-3)_Core Part | Baseline up to month 24 | 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 |
| Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part | Baseline up to month 24 | Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate |
| Annualized rate of new or enlarging T2 lesions_Extension Part | Month 24 up to month 48 | Number of new/enlarging T2 lesions per year on MRI |
| Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part | Month 24 up to month 48 | 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 |
| Number of Adverse events and serious adverse events_Extension Part | Month 24 up to month 48 | Adverse events will be collected throughout the trial. Any safety assessment findings such as laboratory, vital signs, electrocardiogram data that are considered clinically significant or meet the protocol definition of an adverse event will be reported as adverse event or serious adverse event, as appropriate |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Portugal, Slovakia, South Africa, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed