Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

This study is for adults generally between 18 and 75 years old who have been diagnosed with a specific type of scleroderma called "diffuse cutaneous systemic sclerosis." This means your skin has thickened in certain areas, including above your wrists and knees, as well as in your fingers and toes.

You should have been diagnosed with scleroderma fairly recently – no more than 7 years ago – and your symptoms should not be too mild or too severe. We'll also check your lung function to make sure you meet certain requirements.

There are also some reasons why you might not be able to join. For example, if you have certain heart or lung conditions, kidney problems within the last six months, severe stomach or gut issues, or active tuberculosis, you might not be eligible. We also can't include you if you have another significant rheumatic disease.

If you decide to take part, you'll first go through a screening process to see if you meet all the requirements. If eligible, you'll be randomly assigned to receive either tibulizumab or a placebo for 24 weeks. Neither you nor your study doctor will know which one you're receiving during this time. After 24 weeks, everyone who continues will receive tibulizumab for an additional 28 weeks.

During the study, you'll have regular visits to the clinic for check-ups. These visits will include health assessments, physical examinations, and possibly blood tests, urine tests, and specialized tests to monitor your scleroderma and overall health, especially your lungs. The total time you'd be involved in the study is about 52 weeks.