Clinical Trials Directory

Participants will take part in the main study, including screening, treatment, and follow up, for about 3 years. After receiving the study treatment, they will continue in a long term safety monitoring program for an additional 15 years so researchers can track their health and any delayed side effects.

We are doing this study to find out if an experimental drug called CABA-201 (the study drug) is a safe and effective option for people with systemic sclerosis.

This is an observational study and will only be a one-time saliva sample and a completion of a questionnaire.

You will be in this study for about 122 weeks. The study has three parts called Screening, Treatment, and Follow up. During screening, which can last up to six weeks, doctors will do tests to see if you can join. If you qualify, you will be placed by chance into one of two groups. One group will get a study drug called anifrolumab, and the other will get a placebo, which looks like the medicine but has no active drug. You will also keep taking your regular medicines for polymyositis or dermatomyositis. You must stay on the same dose of your regular medicines for at least the first eight weeks of the study.

After a one-time sample collection deidentified information about the study participants treatment and outcomes will be collected regularly from their medical records and entered into the Duke REDCap system for up to 8 years after enrolling in the study. Samples may be collected again if the study participant experiences a flare up of their disease.

People in this study will come to the clinic about once a month for up to one year. They will be placed into one of two groups by chance. One group will receive the study medicine, and the other group will receive a placebo, which has no active medicine. Neither the participants nor their doctors will know which treatment they are receiving. The study medicine is designed to block two proteins called BAFF and APRIL. These proteins can help certain immune cells cause inflammation in people with Sjogren disease. Researchers want to learn if reducing this inflammation can help improve symptoms and if the treatment is safe for patients.