Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remibrutinib oral treatment, Ocrelizumab.
- Who it may be relevant to
- Registry conditions: Relapsing Multiple Sclerosis. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +14
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Drug Remibrutinib oral treatment
Remibrutinib tablet taken daily - Drug Ocrelizumab
Ocrelizumab 600mg infusion or 920mg injection
Primary outcome measures
- Annualized rate of new or enlarging T2 lesions_Core Part [Time frame: Baseline up to month 24]
Secondary outcome measures (5)
- Participants with no evidence of disease activity-3 (NEDA-3)_Core Part [Time frame: Baseline up to month 24]
- Number of adverse events (AEs) and serious adverse events (SAEs)_Core Part [Time frame: Baseline up to month 24]
- Annualized rate of new or enlarging T2 lesions_Extension Part [Time frame: Month 24 up to month 48]
- Participants with no evidence of disease activity-3 (NEDA-3)_Extension Part [Time frame: Month 24 up to month 48]
- Number of Adverse events and serious adverse events_Extension Part [Time frame: Month 24 up to month 48]
Eligibility criteria
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
Other inclusion and exclusion criteria may apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 40 centers
- Perseverance Research Center — Scottsdale
- University of California Irvine — Irvine
- Medstar Washington Hospital Center — Washington D.C.
- Neurology of Central FL Res Ctr — Altamonte Springs
- University of Florida — Gainesville
- Neurology Associates PA — Maitland
- Aqualane Clinical Research — Naples
- Advent Health Orlando — Orlando
- … and 32 more centers
France · 11 centers
- Novartis Investigative Site — Bordeaux
- Novartis Investigative Site — Clermont-Ferrand
- Novartis Investigative Site — Lille
- Novartis Investigative Site — Marseille
- Novartis Investigative Site — Nice
- Novartis Investigative Site — Nîmes
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Poitiers
- … and 3 more centers
Spain · 11 centers
Center list to be confirmed — check the primary protocol.
Germany · 8 centers
- Novartis Investigative Site — Berlin
- Novartis Investigative Site — Bochum
- Novartis Investigative Site — Essen
- Novartis Investigative Site — Greifswald
- Novartis Investigative Site — Heidelberg
- … and 3 more centers
Italy · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 4 centers
- Novartis Investigative Site — Rosario
- Novartis Investigative Site — Rosario
- Novartis Investigative Site — Buenos Aires
- Novartis Investigative Site — Caba
Australia · 4 centers
- Novartis Investigative Site — Melbourne
- Novartis Investigative Site — Parkville
- Novartis Investigative Site — Liverpool
- Novartis Investigative Site — St Leonards
Brazil · 4 centers
- Novartis Investigative Site — Porto Alegre
- Novartis Investigative Site — Rio Grande
- Novartis Investigative Site — São Paulo
- Novartis Investigative Site — São Paulo
Canada · 4 centers
- Novartis Investigative Site — Edmonton
- Novartis Investigative Site — Vancouver
- Novartis Investigative Site — Lévis
- Novartis Investigative Site — Montreal
Czechia · 4 centers
- Novartis Investigative Site — Brno
- Novartis Investigative Site — Hradec Králové
- Novartis Investigative Site — Jihlava
- Novartis Investigative Site — Pardubice
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Greece · 3 centers
Center list to be confirmed — check the primary protocol.
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 3 centers
Center list to be confirmed — check the primary protocol.
Belgium · 2 centers
- Novartis Investigative Site — Bruges
- Novartis Investigative Site — Overpelt
Denmark · 2 centers
- Novartis Investigative Site — Aarhus N
- Novartis Investigative Site — Glostrup Municipality
Mexico · 2 centers
Center list to be confirmed — check the primary protocol.
Slovakia · 2 centers
Center list to be confirmed — check the primary protocol.
South Africa · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06846281 · CLOU064C12306 · 2023-509275-17