A Study to See if Anifrolumab is Safe and Works Well in Adults with Systemic Sclerosis Compared to a Placebo
We are doing this study to see if a medicine called anifrolumab is safe to use in adults with systemic sclerosis. We also want to find out if the medicine helps with disease symptoms and if it stops the disease from getting worse.
Why this Research Matters
Anifrolumab is a new medicine for people with systemic sclerosis. Anifrolumab is already used to treat adults with lupus but has not been tested and approved to treat adults with systemic sclerosis. This study will help researchers see if this is a safe and effective medicine for people with systemic sclerosis.
What to Expect
If you want to join this study, you will have a visit to see if you qualify. At this visit, the study doctor will do tests to see if you can join. This may include checking how well your heart is working (ECG and echocardiogram), your lung health (CT scan and chest X-ray), and a lung function test (spirometry). You will also fill out several questions, have a physical exam, and we will check your weight and vitals (like blood pressure, heart rate, and temperature). If you qualify and want to join, you will be put into one of two groups by chance, like flipping a coin. You won’t get to choose your group. One group will get anifrolumab, and the other group will get a placebo. A placebo looks the same and is given the same way, but it doesn’t have any real medicine. In this part of the study, you will get a shot once a week for 52 weeks. The shot will have either anifrolumab or the placebo. You and your caregiver will learn how to give the shot. You, your caregiver, and the study team won’t know which one you are getting. You will go to 8 in-person visits. At these visits, you will answer questions and get tests to check your health. You will also have one phone visit. After the first year, you will get anifrolumab by weekly shots for another 52 weeks. This time, you and the study team will know you are getting anifrolumab. You will have 5 in-person visits to answer questions and get tests to check your health.
Study Duration
You will be in the study for 2 years and 3 months. You will have a total of 17 study visits. You will have 15 fifteen in-person visits. The other 2 visits can be done over the phone or video call.
Who can Participate
You can join this study if:
- You are an adult between 18 to 70 years old.
- You have systemic sclerosis that is limited or diffuse skin type.
- Your first symptom (not including Raynaud's) must have started within the last 6 years from the day you joined the study.
- You are a woman who can get pregnant, you must have a negative pregnancy test.
- You have a certain antibody in your blood called the anticentromere antibody.
- You have a serious heart or lung problem.
- You had a kidney poblem called systemic sclerosis renal crisis within the past 12 months, and your kidney function is low.
- You have other health problems that are like systemic sclerosis such as
- Lupus with a certain antibody (anti-double-stranded DNA)
- Rheumatoid arthitis with a certain antibody (anti-CCP)
- Other conditions that look like systemic sclerosis like scleromyxedema or eosinophilic fascitis
- You have or had other inflammatory diseases, like bowel or skin disease that could affect the study or require special treatment.
- You have serious problems with your brain, kidneys, hormones, liver, or stomach that are not caused by systemic sclerosis.
- You had a stem cell or organ transplant.
- You had a serious case of shingles.
- You have cancer now or have had cancer in the last 5 years, except for certain skin cancers or early-stage cervical cancer that was treated.
- You have had major surgery in the last 8 weeks or plan to have surgery during the study.
- You have a current infection or get infections often.
Study ID
Protocol Number: 24-1892
More information available at ClinicalTrials.gov: NCT05925803
Compensation Information
Meet the Team
Principal Investigator