The study focuses on demyelinating diseases of the central nervous system, a group of conditions where the protective covering of nerve fibers is damaged, leading to problems such as weakness, vision loss, or coordination difficulty. It includes people who have had a first episode called CIS, the more common form known as RRMS, as well as disorders identified by specific antibodies such as AQP4+ NMOSD and MOGAD. All participants receive the standard anti‑inflammatory steroid intravenous methylprednisolone, and the trial tests whether adding an experimental antibody‑removing drug called efgartigimod, which works by targeting the protein FcRn, leads to better recovery compared with a placebo. The purpose of the study is to determine if the new drug improves the chance of complete remission after a moderate‑to‑severe attack.
After a qualifying attack, participants are randomly assigned to receive either the experimental infusion or the placebo, both given through a vein. They continue the usual steroid treatment and are followed for about three months, with visits to check vision, strength, walking speed, hand dexterity, and overall disability using simple tests and questionnaires. The study records whether additional rescue treatments are needed, how quickly symptoms improve, and any side effects, allowing researchers to see if the added drug provides a meaningful benefit.
Austria 
Germany 
