This clinical trial is focused on studying the effects of a new treatment for Multiple Sclerosis (MS), a disease that affects the brain and spinal cord, leading to symptoms like fatigue, difficulty walking, and vision problems. The treatment being tested is called SAR443820, which is taken as a film-coated tablet. The study will compare the effects of this treatment to a placebo, which looks like the treatment but does not contain the active substance. The main goal is to see how SAR443820 affects levels of a protein in the blood called serum neurofilament, which can be a marker of nerve damage in MS.
The study is divided into two parts. In the first part, participants will be randomly assigned to receive either SAR443820 or a placebo for a certain period. This part is “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. After this phase, all participants will have the opportunity to receive SAR443820 in an “open-label” extension, where everyone knows they are receiving the treatment. This will help researchers understand the long-term effects of the treatment.
Throughout the study, participants will undergo regular check-ups and tests, including MRI scans, to monitor changes in their condition and any side effects. The study aims to provide valuable information on whether SAR443820 can help reduce nerve damage in people with Multiple Sclerosis and improve their quality of life over time.
Belgium 
Bulgaria 
France 
Germany 
Italy 
Poland 
Spain 
