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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06846281
Registration number
NCT06846281
Ethics application status
Date submitted
24/02/2025
Date registered
26/02/2025
Date last updated
11/09/2025
Titles & IDs
Public title
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
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Scientific title
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
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Secondary ID [1]
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CLOU064C12306
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Remibrutinib oral treatment
Treatment: Drugs - Ocrelizumab
Experimental: Remibrutinib Core - Remibrutinib tablet taken orally
Active comparator: Ocrelizumab Core - Ocrelizumab at standard dose and route of administration (i.v. or s.c) per label
Experimental: Remibrutinib Extension - Remibrutinib tablet taken orally
Experimental: Remibrutinib Extension (Ocrelizumab in Core) - Remibrutinib tablet taken orally
Treatment: Drugs: Remibrutinib oral treatment
Remibrutinib tablet taken daily
Treatment: Drugs: Ocrelizumab
Ocrelizumab 600mg infusion or 920mg injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualized rate of new or enlarging T2 lesions_Core Part
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Assessment method [1]
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Number of new/enlarging T2 lesions per year on MRI at month 24 (relative to baseline)
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Timepoint [1]
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Baseline up to month 24
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Secondary outcome [1]
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Participants with no evidence of disease activity-3 (NEDA-3)_Core Part
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Assessment method [1]
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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
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Timepoint [1]
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Baseline up to month 24
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Secondary outcome [2]
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Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part
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Assessment method [2]
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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
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Timepoint [2]
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Baseline up to month 24
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Secondary outcome [3]
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Annualized rate of new or enlarging T2 lesions_Extension Part
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Assessment method [3]
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Number of new/enlarging T2 lesions per year on MRI
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Timepoint [3]
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Month 24 up to month 48
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Secondary outcome [4]
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Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part
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Assessment method [4]
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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
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Timepoint [4]
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Month 24 up to month 48
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Secondary outcome [5]
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Number of Adverse events and serious adverse events_Extension Part
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Assessment method [5]
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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
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Timepoint [5]
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Month 24 up to month 48
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
Other inclusion and exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/07/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/01/2032
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Actual
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Sample size
Target
360
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Melbourne
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Recruitment hospital [2]
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Novartis Investigative Site - Parkville
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Recruitment hospital [3]
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Novartis Investigative Site - Liverpool
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Recruitment hospital [4]
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Novartis Investigative Site - St Leonards
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Quebec
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Country [2]
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South Africa
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State/province [2]
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Cape Town
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06846281
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06846281
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