Clinical Trial: A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated

Brief Summary: The aim of the trial is to assess the safety and efficacy of the orally-administered, selective complement C5a receptor inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Detailed Summary:

Complement 5a and its receptor C5aR (CD88) is involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

This is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate the safety and efficacy of the orally-administered, selective C5aR inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) treated concomitantly with Rituximab or Cyclophosphamide/Azathioprine.

Sponsor: ChemoCentryx

Current Primary Outcome:

• Remission [ Time Frame: 26 weeks ]
  The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS) at Week 26
• Sustained remission [ Time Frame: 52 weeks ]
  The proportion of patients achieving sustained disease remission assessed by BVAS at Week 52

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Adverse events coded by MedDRA [ Time Frame: 60 weeks ]
  Patient incidence of treatment-emergent serious adverse events, adverse events, and withdrawals due to adverse events
• Glucocorticoid-induced toxicity [ Time Frame: 26 weeks ]
  Glucocorticoid-induced toxicity as measured by the Glucocorticoid Toxicity Index
• Response rapidity [ Time Frame: 4 weeks ]
  Remission assessed by BVAS at week 4
• Health-related quality of life [ Time Frame: 52 weeks ]
  Change in health-related quality-of-life based on the Short Form-36 version 2 component and domain scores and the EuroQOL-5D-5L visual analogue scale (in mm) and index
• Estimated glomerular filtration rate (eGFR) [ Time Frame: 52 weeks ]
  Change from baseline in eGFR in mL/min/1.73^2
• Urinary albumin:creatinine ratio (UACR) [ Time Frame: 52 weeks ]
  Change from baseline in UACR in mg/g creatinine
• Urinary monocyte chemoattractant protein-1 (MCP-1):creatinine ratio [ Time Frame: 52 weeks ]
  Change from baseline in urinary MCP-1:creatinine ratio in pg/mg creatinine
• Vasculitis Damage Index [ Time Frame: 52 weeks ]
  Change from baseline in the Vasculitis Damage Index (VDI)

Original Secondary Outcome: Same as current

Information By: ChemoCentryx

Dates:
Date Received: December 11, 2016
Date Started: December 2016
Date Completion: October 2019
Last Updated: May 15, 2017
Last Verified: May 2017