A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis

To join this study, a young person must be between 2 and 17 years old. They need to have been diagnosed with generalised Myasthenia Gravis, and doctors must have found specific antibodies in their blood. Also, their current treatments for Myasthenia Gravis shouldn't be working well enough for them, but they need to be on a steady dose of these existing medicines for at least a month before joining.

There are also some things that would mean someone cannot take part. For example, if a young woman could become pregnant, she cannot be pregnant or breastfeeding, and must agree to use effective birth control during the study. Participants cannot have certain other medical conditions or have had particular treatments recently, like some vaccinations, or surgery on their thymus gland in the last three months.

The study also cannot include anyone who has worsening muscle weakness due to an infection or another medicine, or if their Myasthenia Gravis didn't improve after a specific treatment called plasma exchange (PLEX). If they've had cancer, they usually need to have been free of it for at least three years, though some types of skin cancer might be an exception.

If you decide to take part, you or your child will be in the study for up to 14 weeks. During this time, they will receive injections of the study medicine, efgartigimod PH20 SC. The research team will arrange for regular check-ups to see how the medicine is affecting your child, track how much of it is in their body, and look for any side effects. This involves visits to the clinic for assessments and monitoring. After the 14 weeks, if suitable, there might be an option to continue the treatment in a follow-up study.