EMD Serono/Merck MS200527-0080
A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety
The purpose of this research study is to learn how safe the study drug, called evobrutinib, is and whether it works. The primary research question is to see whether evobrutinib can reduce relapses, compared to Aubagio® (teriflunomide), a medication already being used to treat RMS. Other aspects being studied are:
- How the study drug and Aubagio® (teriflunomide) compare in slowing disability, your health, your tiredness, and your functioning
- How well you are able to tolerate the study drug
- How quickly the study drug is broken down by the body (called pharmacokinetics [PK])
- How substances in the body (called biomarkers) are related to your RMS
- How the study drug might affect the activity of your genes.
This is a Phase 3 study. This means that the study drug has been previously tested in healthy participants, and smaller studies have already been completed in patients with RMS. In this study, the study drug will be tested in a larger group of patients with RMS.
We anticipate that approximately 930 people will participate in this study. The study will be conducted in approximately 300 medical centers in about 35 countries globally. Your participation in this research study will last for approximately 2 years and 4 months.