Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06846281
Intervention or treatment
DRUG: Remibrutinib oral treatment
DRUG: Ocrelizumab
Conditions
- Relapsing Multiple Sclerosis
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Novartis Investigative Site
Select from list below to view details:
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Liverpool, Australia
Novartis Investigative Site
St Leonards, Australia
Loading map...
Who is running the clinical trial?
Novartis Pharmaceuticals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Remibrutinib Core
| Drug: Remibrutinib oral treatment |
ACTIVE_COMPARATOR: Ocrelizumab Core
| Drug: Ocrelizumab |
EXPERIMENTAL: Remibrutinib Extension
| Drug: Remibrutinib oral treatment |
EXPERIMENTAL: Remibrutinib Extension (Ocrelizumab in Core)
| Drug: Remibrutinib oral treatment |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of new or enlarging T2 lesions_Core Part | Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline) | Baseline up to month 24 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Participants with no evidence of disease activity-3 (NEDA-3)_Core Part | 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 | Baseline up to month 24 |
| Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part | 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 | Baseline up to month 24 |
| Annualized rate of new or enlarging T2 lesions_Extension Part | Number of new/enlarging T2 lesions per year on MRI | Month 24 up to month 48 |
| Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part | 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 | Month 24 up to month 48 |
| Number of Adverse events and serious adverse events_Extension Part | 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 | Month 24 up to month 48 |
References
Clinical Trials Gov: Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.Other trials to consider
Loading suggested trials...
