A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis

To join this study, you need to be an adult, 18 years or older, and have received a diagnosis of systemic sclerosis. Doctors will check your medical records and some blood tests to confirm your diagnosis meets the study requirements. You'll also need to have certain levels of skin thickening and how much your condition affects your daily activities, as measured by standard assessments.

There are also some specific blood test results that need to be positive, specifically an 'antinuclear antibodies (ANA)' test, and another marker related to your type of SSc and how recently your symptoms started.

However, some conditions might mean you can't join. For example, if you have certain types of heart or lung problems, severe digital vasculopathy (problems with blood flow to your fingers/toes) in the last few months, or other rheumatologic autoimmune diseases (unless it's secondary Sjögren's syndrome or fibromyalgia), you might not be eligible. We also can't include people who have had certain kidney emergencies or if your skin thickening is due to other specific conditions, rather than SSc.

If you decide to join this study, it would last for up to 15 months in total. First, there's a 'screening period' where doctors will check if you meet all the requirements. If you do, you'll then enter the 'treatment period' which lasts for up to 48 weeks (just under a year).

During the treatment period, you'll be randomly assigned to receive either the study medicine, efgartigimod PH20 SC, or the placebo. This means you have a two-thirds chance of getting the active medicine and a one-third chance of getting the placebo. Neither you nor your study doctor will know which one you are receiving. The medicine is given as an injection under the skin.

You'll have regular visits to the clinic for assessments, blood tests, and to get your study medicine. After the treatment period, there will be a 'safety follow-up period' where your health will continue to be monitored for a while longer to ensure there are no lasting issues. All these visits and assessments are important for us to gather all the necessary information about the new medicine.