Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Studying the Long-term Safety & Effectiveness of Avacopan in People with ANCA-associated Vasculitis

This study wants to see if avacopan is safe and works well for people with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. We also want to find out if it helps prevent the disease from coming back.


Why this Research Matters

If you qualify and choose to take part, you'll be randomly placed into one of three groups, like flipping a coin. The study drug is testing a drug called avacopan and comparing it to a placebo (a pill that looks the same but has no active medicine). The first group will get avacopen for 5 years, the second group will get avacopan for 1 year followed by placebo for 4 years, and the third group will get placebo for five years. Neither you nor the study team will know which group you're in. You will have 26 visits over about 5 years and 3 months. At your first visit, you will fill out surveys about your health, medical history, and medications. You will get a physical exam, a heart test (called an ECG), and a chest x-ray. You will have your vital signs like heart rate, blood pressure, and temperature checked. You will give a small blood and urine sample. At later visits, you will do many of the same things, like fill out surveys, get physical exams, and have your vital signs checked. We'll ask you if you've had any side effects from the study drug, go over the other medications you're taking, and check if your symptoms have gotten worse. If you complete all study visits, you can earn up to $1,110.


Who can Participate

Adult

You may be able to take part this study if you are 18 or older and have recently been diagnosed with, or had a return of, granulomatosis with polyangiitis or microscopic polyangiitis. This study is for people who need treatment with cyclophosphamide or rituximab. You cannot take part in this study if you have another autoimmune disease that affects many parts of your body, like lupus, rheumatoid vasculitis, or Sjogren's syndrome. You also can't take part if you've had treatment with cyclophosphamide (CYC), dialysis, or plasma exchange in the last 12 weeks. People with serious lung bleeding who need a breathing machine, or those who need strong immune-suppressing drugs like steroids, can't be in the study. You also can't take part if you're currently taking azathioprine (AZA), mycophenolate, or methotrexate, and haven't stopped them before starting cyclophosphamide or rituximab. If you've had a kidney transplant or had cancer in the last 5 years (except for some skin, cervical, or breast cancers), you can't join the study. People who have active hepatitis B virus, hepatitis C virus, or HIV or test positive for tuberculosis (TB) at their first visit, won't be able to join. Low white blood cell counts, serious liver problems, recent infections needing antibiotics, and serious heart issues in the last 12 weeks also mean you can't be in the study.


Study ID

Protocol Number: 24-2207


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Elena Weinstein, MD

Principal Investigator