Are you living with ANCA-Associated Vasculitis?

Learn about ADVOCATE, a clinical research study for people with two types of vasculitis

About ADVOCATE

We want to find a new treatment option that may work for people with ANCA-associated vasculitis

What is the purpose of the ADVOCATE trial?
The purpose of the ADVOCATE trial is to learn if avacopan (previously called CCX168) can provide benefits to patients by being safe and effective in improving vasculitis disease activity, kidney function, and/or quality of life.

Have other people with ANCA-associated vasculitis used avacopan in clinical trials?

Avacopan has previously been studied in two Phase II trials in 109 patients with ANCA-associated vasculitis.

  • The CLASSIC trial in 42 patients was designed to test the safety of adding avacopan to other medications your physician may prescribe for treatment of vasculitis, including prednisone and cyclophosphamide or rituximab.
  • The CLEAR trial in 67 patients compared the combination of avacopan with cyclophosphamide or rituximab to the combination of high dose prednisone with cyclophosphamide or rituximab. The avacopan group showed rapid improvement in disease activity and favorable safety in this 3-month trial. Results from the CLEAR trial have been published in the peer-reviewed Journal of the American Society of Nephrology (Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis, David R.W. Jayne et al; published April 11, 2017)

The ADVOCATE trial is similar to the CLEAR trial, but will include more patients who will be dosed with avacopan for a longer period of time. The ADVOCATE trial will test the safety and efficacy of avacopan for 12 months and will include approximately 300 patients.

In addition to testing the effect of avacopan on improving active vasculitis, ADVOCATE will also test the effect of avacopan on preventing a recurrence of vasculitis.

Who can take part in the ADVOCATE trial?
The ADVOCATE trial is for people with active ANCA-associated vasculitis.  You should talk to your doctor about whether taking part in a clinical trial is right for you.

You may be able to join the study if you:

  • Are 18 years or older; in certain countries and study centers, patients 12-17 years old may also participate;
  • Have been diagnosed with one of the following kinds of ANCA-associated vasculitis
    • Granulomatosis with polyangiitis, also called GPA or Wegener’s
    • Microscopic polyangiitis, also called MPA
  • Require the addition of cyclophosphamide or rituximab to gain better control of your disease activity
  • Have not had a kidney transplant

There are other eligibility criteria that you must meet to participate. The study staff can discuss these criteria with you in greater detail.  Visit our “Study Locations” section to find a study site near you.

What will happen during the study?
If you qualify for, and decide to participate in, the ADVOCATE trial, your participation will last about 60 weeks. During this time, you will be asked to:

  • Take the study medication as instructed by the study doctor
  • Answer questionnaires about your health
  • Have your urine and blood collected at all visits
  • Follow all directions from the study staff
  • Make regular visits to the clinic during the study period
  • Attend approximately 16 study visits

Study participants will be randomized to receive either avacopan or standard of care therapy.  Each person will have a 50 percent chance of receiving avacopan. During the study, neither you nor your doctor will know the treatment group to which you are assigned.

About Avacopan

AVACOPAN is an investigational medicinal product that is being tested in patients with ANCA-associated vasculitis

What is avacopan?
Avacopan (previously called CCX168) is an investigational medicinal product that is being tested to learn if it will be safe and effective for the treatment of people with active ANCA-associated vasculitis. Avacopan is manufactured as pills that are taken by mouth.

What is an investigational medicinal product?
An investigational medicinal product is a medication that is still being studied in clinical trials. It has not been approved for treating patients by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other Regulatory Authority.

How does avacopan work?
In ANCA-associated vasculitis, the immune system is activated in a way that can cause inflammation and damage to blood vessels and organs including the kidney. Avacopan was developed to reduce activation of a part of the immune system that is known to be active in ANCA-associated vasculitis.

Specifically, avacopan binds and blocks activation of a protein called the complement 5a receptor (C5aR). C5aR causes the activation of cells that can cause destructive inflammation in ANCA-associated vasculitis. By blocking C5aR, avacopan reduces the inflammatory effects of C5aR.

Have other people with ANCA-associated vasculitis used avacopan?
Avacopan has previously been studied in two Phase II trials in 109 patients with ANCA-associated vasculitis.

  • The CLASSIC trial in 42 patients tested the safety of adding avacopan to other medications that are used for treatment of vasculitis, including prednisone, cyclophosphamide and rituximab.
  • The CLEAR trial in 67 patients compared the combination of avacopan with cyclophosphamide or rituximab to the combination of high dose prednisone with cyclophosphamide or rituximab. Results from the CLEAR trial have been published in the peer-reviewed Journal of the American Society of Nephrology (Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis, David R.W. Jayne et al; published April 11, 2017)

About ANCA-Vasculitis

ANCA-associated vasculitis is a rare condition that can affect many different organ systems, and commonly involves the kidneys

What is vasculitis?
Vasculitis means “inflammation of the blood vessels.” Vasculitis can occur alone, or together with other disorders. There are many forms of vasculitis.

What is ANCA-associated vasculitis?
ANCA is a short name for Anti-Neutrophil Cytoplasmic Antibodies. Antibodies are proteins that your body makes to fight infections. Sometimes the body makes antibodies that bind to your own cells. Most such antibodies, also called autoantibodies, are harmless. However, some autoantibodies can cause inflammation and damage.

ANCA are antibodies that can lead to inflammation of blood vessels. Inflammation of blood vessels can cause damage to organs, such as the kidneys. When this occurs, we name the condition ANCA-associated vasculitis.

There are two kinds of ANCA-associated vasculitis; both types will be studied in the ADVOCATE trial:

  • Granulomatosis with polyangiitis, which is also called Wegener’s or GPA
  • Microscopic polyangiitis, which is also called MPA

Treatment of ANCA-associated vasculitis depends on the severity and activity of the disease. Your doctor chooses the best medications for your condition, and often changes the dose and kind of medication as the condition changes. The most common medications for severe active disease are cyclophosphamide (also called Cytoxan or Endoxan and other names), rituximab (also called Rituxan or MabThera), and high dose glucocorticoids (also called steroids, corticosteroids, prednisone, prednisolone and other names). These medicines and others have helped many people with ANCA-associated vasculitis. There is more work to be done to find treatments that work faster, help more people, and have fewer side effects.

That’s why the ADVOCATE trial is being done. We hope to find a new treatment option that may work for people with ANCA-associated vasculitis.

FAQs

You can visit any doctor to meet your needs during the study. You should let your study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit. You should also let your other doctors know that you are participating in a clinical trial.

Clinical research studies are done to test investigational medications for diseases and conditions. Studies help determine if investigational medications are safe to use and work to improve the health of people. Before any medication can be approved and made available to the general public, it has to go through several phases of clinical research.

People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help them and others in the future.

Clinical research studies follow a specific set of standards and are closely regulated to help ensure the safety of all participants. Safety precautions are put in place to try and protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is reviewed by an Institutional Review Board, which is a group of people that is responsible for safeguarding the safety and rights of research subjects. Before you participate in any clinical research study, you will review potential risks and benefits, and the study staff will answer any questions you may have.

You can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.

Study participation is completely voluntary. You do not need to take part in the study, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.

Study Locations

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