This clinical trial is focused on studying a condition called generalized myasthenia gravis, which is a chronic autoimmune disorder that causes muscle weakness. The study is investigating a treatment called rozanolixizumab, also known by its code name UCB7665. Rozanolixizumab is a solution for injection that is being tested to see if it is safe and effective for children with this condition. The purpose of the study is to assess the long-term safety and tolerability of multiple treatment cycles with rozanolixizumab in pediatric participants.
Participants in the study will receive treatment cycles with rozanolixizumab over a period of time. The study will monitor for any serious side effects or adverse events that may occur during the treatment. Additionally, the study will look at changes in the levels of a protein in the blood called Immunoglobulin G (IgG), which plays a role in the immune system, as well as changes in the symptoms of myasthenia gravis. The study aims to provide valuable information on how well the treatment works and how safe it is for children with generalized myasthenia gravis.
Throughout the study, participants will be closely observed to ensure their safety and to gather data on the effectiveness of rozanolixizumab. The study is designed to help understand if this treatment can be a viable option for managing symptoms in children with generalized myasthenia gravis, potentially improving their quality of life. The study is expected to continue until 2027, providing a comprehensive evaluation of the treatment’s impact over time.



Italy
Poland