This study is looking at a condition called Facioscapulohumeral Muscular Dystrophy, also known as FSHD, which is a genetic disorder that causes progressive weakness of the muscles, particularly affecting the face, shoulder blades, and upper arms. The study will test a medication called AOC 1020, which is given through a vein as an infusion. Some participants will receive AOC 1020 while others will receive placebo or 0.9% Saline for IV administration. The purpose of the study is to evaluate how well AOC 1020 works on functional mobility, which means the ability to move and perform daily activities.
Participants in this study will be randomly assigned to receive either the active medication or placebo, and neither the participants nor the doctors will know which treatment is being given during the study. The study will last for 78 weeks, which is about 18 months. During this time, participants will receive regular infusions of the study medication and will be monitored to see how their condition changes. The main focus will be on measuring changes in walking speed over a distance of 10 meters, which helps doctors understand if the treatment is helping with movement and mobility.
Throughout the study, various assessments will be performed to measure different aspects of the disease, including how well the upper and lower body muscles are working, how long it takes to stand up and walk a short distance, and how the condition affects quality of life. Participants will also be asked about pain levels, fatigue, and their overall impression of how severe their symptoms are and whether they notice any changes. Blood samples will be taken to measure certain markers that can indicate disease activity and muscle damage.



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