*Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing MS_02
Research type
Research Study
Full title
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
IRAS ID
1005851
Contact name
Angeline Nato
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-005929-89
Clinicaltrials.gov Identifier
Research summary
The main purpose of the study is to fi nd out if patients treated with remibrutinib may experience fewer MS relapses than patients treated with teriflunomide (Aubagio®). Teriflunomide is an approved medication for the treatment of relapsing remitting MS. Approximately 800 patients with relapsing multiple sclerosis, between the ages of 18 and 55 years are being invited to join this study.
Remibrutinib (LOU064) is a medicine, which has not been approved by any Health Authority for the treatment of people with relapsing MS. Remibrutinib is currently not “on the market” for RMS in any country. Data have shown that remibrutinib is a potent and selective inhibitor of Bruton’s tyrosine kinase (BTK), an enzyme responsible for functioning of B-lymphocytes. B-lymphocytes are a type of white blood cell involved in the development of MS. Based on it's action, remibrutinib may have beneficial clinical effects in a variety of autoimmune and chronic inflammatory diseases including RMS.
The reason for the use of teriflunomide in this study is to find out if remibrutinib is better than teriflunomide as a treatment for relapsing MS. Since we do not know which medicine is best, we need to make comparisons.
The Core Part will have screening, treatment and safety follow up periods. To ensure that the study remains blinded (i.e. that the patient or the Study Doctor do not know which treatment the patient is receiving), as well as the active treatment that a patient is assigned, the patient will also receive placebo tablets/capsule of the other treatment. This means during the treatment period, half of the patients will receive remibrutinib and placebo and half will receive teriflunomide and placebo, for a maximum of up to 30 months (~2.5 years). This is followed by an Extension Part which will have treatment and safety follow up periods; during the treatment period remibrutinib is provided for a maximum of up to 5 years to all patients who have completed core part of study.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0243
Date of REC Opinion
23 Sep 2022
REC opinion
Further Information Favourable Opinion