This clinical trial is focused on studying the safety and effectiveness of a new treatment for people with relapsing forms of Multiple Sclerosis (MS). Multiple Sclerosis is a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The study will test a medication called BIIB091, both on its own and in combination with another medication called Diroximel Fumarate (also known as Vumerity). These medications are being tested to see how well they work in reducing inflammation in the central nervous system, which is a key feature of MS.
The trial is divided into two parts. In the first part, participants will receive BIIB091 by itself to assess its safety and how well it is tolerated. In the second part, participants will receive a combination of BIIB091 and Diroximel Fumarate, or Diroximel Fumarate alone, to compare the effects on brain inflammation as seen on MRI scans. MRI, or Magnetic Resonance Imaging, is a technique used to create detailed images of the organs and tissues in the body, which helps in monitoring the disease’s activity.
Participants in the study will be randomly assigned to different treatment groups, and the study will be conducted in a way that neither the participants nor the researchers know which treatment is being given, to ensure unbiased results. The study will last for a period of up to 48 weeks for each participant, during which they will receive regular check-ups and monitoring to ensure their safety and to gather data on the effectiveness of the treatments. The goal is to find a treatment that can help manage the symptoms of relapsing forms of Multiple Sclerosis more effectively.
Bulgaria 
Czechia 
Germany 
Italy 
Poland 
Romania 
Spain 