The Phase 3 ADVOCATE trial, evaluating ChemoCentryx‘s investigational drug avacopan (formerly CCX168) for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is now enrolling participants. The update is part of the company’s financial report for the second quarter of 2017.
The study (NCT02994927), which aims to evaluate the safety and effectiveness of orally administered avacopan in inducing and sustaining remission in patients with ANCA-associated vasculitis, is designed to enroll approximately 300 patients.
Participants will receive avacopan for 12 months in combination with either Rituxan (rituximab) or cyclophosphamide/azathioprine. After the one-year period, researchers will assess avacopan’s safety and effectiveness.
The ADVOCATE trial will also determine the effect of orally administered avacopan in preventing disease recurrence, a major negative outcome that current therapies fail to address.
Enrollment is active at 143 sites in 18 countries around the world. The company is expecting enrollment to be complete by mid 2018. Final data collection for assessing primary outcomes is expected in June 2019.
Avacopan is a selective inhibitor of the complement C5a receptor, or C5aR, which is involved in ANCA-associated vasculitis. The drug is part of ChemoCentryx’s platform for developing novel therapies for inflammatory and autoimmune diseases.
Early this year, the U.S. Food and Drug Administration (FDA) granted avacopan orphan drug status for C3 glomerulopathy (C3G), a group of related conditions characterized by high levels of protein in the urine, blood in the urine, reduced amounts of urine, low protein levels in the blood, and swelling, causing the kidneys to malfunction.
The European Medicines Agency (EMA) also granted orphan medicinal product status to avacopan for C3G and for two forms of ANCA-associated vasculitis — microscopic polyangiitis and granulomatosis with polyangiitis.
“We’ve had a highly productive second quarter, activating many new sites in our avacopan Phase III ADVOCATE trial, which is producing a multiplier effect on patient enrollment,” Thomas J. Schall, PhD, president and CEO of ChemoCentryx, said in a press release.
“Now we are launching a clinical trial for avacopan in a second indication, C3G, executing on our ‘pipeline in a drug’ strategy,” he said. “We are also working with regulatory authorities on the design of a third trial, involving our CCR2 inhibitor, CCX140, intended to support registration in patients with focal segmental glomerulosclerosis (FSGS).”