The purpose of this study is to see if an investigational treatment called remibrutinib can help people living with relapsing multiple sclerosis.
You may be eligible for the study if you:
- Are age 18 - 55
- Have a diagnosis of relapsing multiple sclerosis
- Either relapsing remitting or secondary progressive
- Have experienced a (documented) relapse in the past year
This clinical study is being done to see if patients treated with a new investigational medicine called remibrutinib experience fewer MS relapses than patients treated with teriflunomide (also known as the approved medication Aubagio®).
Remibrutinib blocks the enzyme Bruton’s tyrosine kinase (BTK), thought to play a role in MS. Because we do not yet know if remibrutinib is better than teriflunomide for the treatment of relapsing MS, this study will compare both drugs.
The study has two parts. The first is the Core Part, which is made up of screening, treatment, and follow-up periods. You may be in the Core Part of the study for up to approximately 30 months and will have up to 14 site visits. If you decide to stop study treatment during the Core Part of the study, you may have an end of treatment visit. At that point, you may choose to either continue to have a schedule of shortened study visits (with fewer assessments) or to stop your participation completely.
If you complete the Core Part on study treatment you will be eligible to enter the Extension Part, which will be made up of treatment and follow-up periods. You may be in the Extension Part for up to 5 years and will have up to 13 site visits.
The drugs being studied, remibrutinib and teriflunomide, are oral therapies. Remibrutinib is taken twice a day and teriflunomide is taken once a day.
During the Core Part of the study, you will have a 50% chance of receiving either remibrutinib or teriflunomide. Neither you nor your study doctor will know which treatment you are receiving.
During the Extension Part of the study, all participants who completed the Core Part on double-blind treatment will receive remibrutinib.
You will be cared for by doctors and nurses who are experienced in treating your condition. The study coordinator will work with you to make being part of the study as easy as possible.
Your health may or may not improve in this study. You may have side effects from the study treatment or study tests. Your participation is valuable, as the information learned from this study may benefit others and help to develop a new therapy for similar conditions.
We want you to be comfortable and confident in the decision to join this study. Please ask any questions you may have.
For additional information about the study, please contact us via the form below.
View study on ClinicalTrials.gov