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Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment

Trial Profile

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Avacopan (Primary) ; Prednisone
  • Indications Anti-neutrophil cytoplasmic antibody-associated vasculitis; Granulomatosis with polyangiitis; Microscopic polyangiitis
  • Focus Therapeutic Use
  • Acronyms CLEAR
  • Sponsors ChemoCentryx
  • Most Recent Events

    • 14 Nov 2022 Results of pooled analysis (n=439) assessing the safety of avacopan from two Phase 2 (CLEAR and CLASSIC) and one Phase 3 studies (ADVOCATE) in patients with ANCA-Associated Vasculitis, presented at the ACR Convergence 2022.
    • 24 Jan 2019 According to a Vifor Pharma media release, the company has withdrawn the Conditional Marketing Approval Application of avacopan for the treatment of ANCA-associated vasculitis which was submitted earlier based on data comprising 12 week dosing on around 67 patients from this trial.
    • 16 Jun 2018 Results evaluating the Effect of Avacopan (Ccx168) on plasma complement levels were presented at the 19th Annual Congress of the European League Against Rheumatism (EULAR)
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