A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.

To join this study, you need to be an adult between 18 and 85 years old and have been diagnosed with generalized Myasthenia Gravis (gMG). Specifically, your gMG needs to be the type confirmed by a blood test showing an 'AChR+' antibody, and your symptoms should fall within certain categories of muscle weakness, but not so severe that you would likely need a breathing machine during the study.

You also need to have been on your current gMG treatments, such as certain medications or other types of therapy like plasma exchange, for at least 6 months before starting the study. Before you begin taking the study medicine, you'll need to make sure you've had certain vaccinations to protect against infections like meningitis and pneumonia, or you might need to take antibiotics for a short time if you can't get vaccinated right away. Don't worry, the study team will guide you through all these requirements.

If you decide to take part, you'll be in the study for at least 6 months, which is about 180 days. You'll either receive the new medicine, iptacopan, or a dummy medicine (placebo). You won't know which one you're getting, and neither will your study doctor – this is called 'double-blind' and helps make the study fair. You'll continue to take your regular gMG medicines throughout this time. You'll have regular visits to the clinic for check-ups, where doctors will monitor your gMG symptoms, overall health, and any side effects.

After the first 6 months, there might be an option to continue in the study for a much longer period, up to 60 months (5 years), where everyone would receive iptacopan openly. Even after you stop taking the study medicine, you'll have two follow-up safety checks: one about a week later and another about a month later, to make sure you're doing well. The study team will explain all the appointments and what to expect in detail.