ChemoCentryx Making Progress Recruiting Patients for Phase 3 Trial of ANCA-Associated Vasculitis Therapy

ChemoCentryx Making Progress Recruiting Patients for Phase 3 Trial of ANCA-Associated Vasculitis Therapy

ChemoCentryx has enrolled 30 percent of the 300 ANCA-associated vasculitis patients it hopes to recruit for a Phase 3 trial assessing the effectiveness of its therapy avacopan.

The company is recruiting patients at more than 185 sites. Those interested in participating (NCT02994927) can visit this website to find a site near them.

Avacopan inhibits a protein known as the complement 5a receptor (C5aR) that is involved in inflammatory signaling in ANCA-associated vasculitis, also known as AAV. A vasculitis is a disease characterized by inflamed blood vessels. If the inflammation is left untreated, it can destroy vessels.

AAV’s full name is anti-neutrophil cytoplasmic antibody-associated vasculitis.

Both the U.S. Food and Drug Administration and European Medicines Agency have designated avacopan an orphan drug. This status is designed to speed up its development and regulatory approval.

ChemoCentryx recently announced that avacopan has received orphan drug designation in Switzerland for the treatment of two AAV subtypes, microscopic polyangiitis and granulomatosis with polyangiitis.

“Our pursuit of new and better medicines for people with orphan diseases has been relentless,” Dr. Thomas J. Schall, ChemoCentryx’s president and CEO, said in a press release. “Dedicated to creating value for patients and shareholders alike, we at CCXI started with basic science in the discovery of novel molecules that selectively inhibit chemo-attractant receptors, which are the molecular guidance systems of destructive inflammatory cells involved in a wide range of diseases and conditions.”

The 12-week Phase 2 CLEAR trial (NCT01363388) showed that avacopan could replace high-dose glucocorticoids as a treatment for vasculitis. Glucocorticoids are steroids that can counter the inflammation in vasculitis but can damage organs if used for a long time.

The main objective of the Phase 3 ADVOCATE trial is to see if avacopan can put AAV into remission. ADVOCATE will also look at whether oral avacopan can prevent the disease from returning — something other therapies are unable to do.

Trial participants will receive either avacopan or another therapy, prednisone, for up to 12 months. Both treatments will be given in combination with Genentech’s Rituxan (rituximab) or cyclophosphamide, followed by azathioprine.

In addition to seeing whether avacopan can put patients’ vasculitis into remission, researchers will look for any adverse events the drug generates, at glucocorticoid-triggered toxicity that patients experience, their health-related quality of life, and other measures.

4 comments

  1. wendy dixon says:

    I am interested in the study. However The methotrexate they used on me before was very toxic for me. I have wegners granulomatosis. I had a part of my right lung removed. And then had a blood clot shortly after in the lung. I am living proof. I am tough. I had rituximan in 2015 but I have constant nodules throughout my body. I have them in my spine. I have lesions on my brain now. I have had nasal ulcerations for 4 years now and never go away. I have a lot of pain at times and fatique

  2. wendy dixon says:

    I was interested in the study. I feel my quality of life is not as good as I would like it to be. I am on disability now and I would rather be working. I have constant pain in both of my lungs. I have severe migraines. My knees buckle all the time. I fall down sometimes and I faint on any kind of exercise I do… So I don’t know what else to do or say. DR keep sending from one dr to another With no help at all. I also get lesions on my head and they are very bothersome. I heal them with Apple cider vinegar. Bactrim no longer helps.

  3. wendy dixon says:

    Is it a pill for or an infusion. I do not like to take pills. I get a very upset stomache now. I am also on CHannel blocker and a beta blocker from this disease

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