CLOU064C12306-A study switching from ocrelizumab with remibrutinib in MS patients
Research type
Research Study
Full 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
IRAS ID
1011566
Contact name
Leander Wyss
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2023-509275-17
ISRCTN Number
ISRCTN06846281
Clinicaltrials.gov Identifier
Research summary
Remibrutinib is an investigational drug under development for various diseases, including relapsing multiple sclerosis (RMS). The purpose of this research study is to determine whether remibrutinib could be a safe and effective alternative therapy for use after anti-CD20 treatment
(ocrelizumab) in the aging RMS population (40 years old or older). This is an open-label (participants and physician/doctor know about the treatment participants are on) clinical trial where participants are treated for up to 48 months (4 years). This clinical trial will have a Screening Period (up to 5 weeks), a Treatment Period (up to 4 years), and a Safety Follow-up Period (4 weeks after the end of study for applicable participants). The Treatment Period has two parts: The first part of the study called the Core Part, and the second part of the study called the Extension Part. During the Core Part, 50% of participants will receive remibrutinib for up to 2 years and 50% will receive ocrelizumab for the same duration. During the Extension Part, all participants who are eligible (all participants completing the 24-month study treatment in the Core Part) and interested in continuing in the study will receive remibrutinib for up to 2 years. After completing the open-label treatment, participants may require an additional 4-week safety follow-up after their last dose of study treatment. Approximately 360 people (men and women) aged 40 years or older who have a diagnosis of RMS and meet the specific eligibility criteria may join this trial. Participants must be receiving ocrelizumab for at least 18 months and have received the last administration of ocrelizumab within 5 to 9 months prior to
enrolment. Participants are not permitted to join this trial if they have any of the following: primary progressive multiple sclerosis (PPMS), progressive multifocal leukoencephalopathy (PML), or other diseases/conditions as specified in the protocol. Participants must not be pregnant or breastfeeding.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0177
Date of REC Opinion
1 Sep 2025
REC opinion
Further Information Favourable Opinion