VynpentaAnti-neutrophil cytoplasmic antibody-associated vasculitis
Development and Regulatory status
Trial or other data
Nov 19: Pivotal PIII ADVOCATE trial met both primary endpoints; with remission rates (assessed by BVAS) at week 26 reaching 72.3% with avacopan compared vs. 70.1% with glucocorticoid standard-of-care (control gp). Sustained remission at 52 weeks was seen in 65.7% in the avacopan gp vs. c54.9% in the control group.
Dec 16: PIII ADVOCATE trial to evaluate the safety and efficacy of avacopan in 300 US patients with ANCA-associated vasculitis or AAV treated concomitantly with rituximab or cyclophosphamide/azathioprine starts (NCT02994927). The primary endpoints will be remission and sustained remission, assessed at 26 and 52 weeks, respectively, using Birmingham Vasculitis Activity Score. The randomised, double-blind, placebo-controlled trial is designed to enrol approximately 300 patients in the US. Collection of primary outcome data is expected to complete Jun 19 .
Jun 16: ChemoCentryx reported positive top-line results from the PII CLASSIC trial designed to evaluate the safety and efficacy of avacopan, administered at a low or a high dose, in 42 Us and Canadian patients with ANCA-associated vasculitis (NCT02222155) .
Jan 16: PII CLEAR trial met its primary endpoint indicating a significant non-inferiority in Birmingham Vasculitis Activity Score (BVAS) response relative to the standard of care, that assessed the safety and efficacy of CCX 168 (avacopan) in patients with ANCA-associated vasculitis or AAV (NCT01363388). The randomised, double-blind, placebo-controlled, three-step trial enrolled 63 patients in Austria, Belgium, Czech Republic, France, Germany, Hungary, the Netherlands, Poland, Sweden and the UK .