LTS17043
Research type
Research Study
Full title
An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis.
IRAS ID
1008539
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-503631-18
Research summary
Tolebrutinib is being developed for the treatment of different forms of MS and it may improve the condition of people with this disease, based on data from a completed study in people with relapsing MS. The potential risks of taking tolebrutinib are bleeding, infection, low blood cell levels, irregular and/or faster heartbeat, and liver injury.
The goal of this extension study is to test the long-term safety of tolebrutinib in adults with different forms of MS who have previously participated in the Phase 2b study or one of the Phase 3 studies (parent studies). This will be done by measuring the number of participants with a side effect or abnormal test related to tolebrutinib during the study. As part of the study, all participants in the UK will find out what treatment they received in the parent study (this will be at different time points based on which parent study they took part in). If from one of the Phase 3 relapsing MS studies and on teriflunomide, either an 11-day accelerated elimination procedure with cholestyramine or a 3-month washout period to reduce teriflunomide levels in the body is required prior to starting open label tolebrutinib. All participants will go on to receive open label tolebrutinib, at a daily dose of 60mg (oral).
Each participant will receive treatment for up to 3 years or until tolebrutinib is commercially available, whichever comes first. There will be approximately 10 visits per participant. Only participants who are enrolled onto one of the previous parent studies will be eligible to take part, and within the UK it will take place in NHS centres.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0715
Date of REC Opinion
15 Nov 2023
REC opinion
Further Information Favourable Opinion