Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

This study is looking for adults aged between 18 and 70 who have been diagnosed with Systemic Sclerosis (Scleroderma) based on specific medical guidelines. You might be suitable if your diagnosis is relatively recent, specifically within six years of your first symptoms that aren't related to Raynaud's phenomenon (a common early symptom affecting blood flow to fingers and toes).

To join, you'll need to meet certain health criteria that indicate your condition is active enough for the study to measure any potential improvements. This includes specific scores on questionnaires about your physical abilities and your skin condition. You can also be taking certain common medications for Scleroderma, such as hydroxychloroquine or mycophenolate, as long as your doses have been stable.

There are also some reasons why you might not be able to join. For example, if you have certain severe heart or lung problems, a history of kidney crisis related to Scleroderma in the last year, or if you have other serious medical conditions not related to Scleroderma that could interfere with the study. The study team will review all your medical information carefully to determine if this study is right for you.

If you join the DAISY study, you'll be involved for a total of about two years and three months. This includes a initial screening period of up to six weeks to check if you're suitable. Once you've been accepted, you'll be randomly assigned to receive either Anifrolumab or a placebo (a dummy treatment) for 52 weeks. Neither you nor your study team will know which one you're receiving during this time. After this first year, everyone who continues in the study will receive the active Anifrolumab treatment for another 52 weeks.

The study medication will be given as an injection under the skin, once a week. This will mostly be done at home, either by yourself, a carer, or a visiting healthcare professional, after you've been trained. There will be around 16 visits to the study clinic over the entire duration, with most visits during the treatment periods happening every 8 to 12 weeks. These visits will involve checks on your health, assessments of your Systemic Sclerosis, and reviewing any side effects. After the treatment phases, there's a final 12-week safety check-up period.