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01
Overview
Phase 2, randomised, double-blind trial in Antineutrophil cytoplasmic antibody-associated vasculitis (AAV) comparing Placebo Control with Avacopan Experimental (2 arms). Primary endpoints: Proportion of Subjects Achieving Disease Response at Day 85 and Safety and tolerability of CCX168 at Day 85. Started Sep 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Control
Placebo + High Dose Prednisone + Background (CYC/RTX)
Avacopan Experimental
Avacopan + Reduced/No Prednisone + Background (CYC/RTX)
03
Who it enrols
Adult patients with new or relapsed ANCA-associated vasculitis (GPA, MPA, or renal limited) requiring cyclophosphamide or rituximab, with eGFR >= 20 mL/min and active disease on BVAS.
04
Endpoints
Primary
Proportion of Subjects Achieving Disease Response at Day 85
Safety and tolerability of CCX168
Secondary
Proportion of Patients Achieving Renal Response at Day 85
Proportion of Subjects Achieving Disease Remission at Day 85
Percent Change From Baseline to Day 85 in BVAS
Change From Baseline to Day 85 in eGFR
Proportion of Subjects Achieving Urinary RBC Count <=5/Hpf
Percent Change From Baseline to Day 85 in UACR
Proportion of Subjects Requiring Rescue IV or Oral Glucocorticoid Treatment
Change From Baseline to Day 85 in the Vasculitis Damage Index
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