A Study to Evaluate the Safety & Efficacy of CCX168 in Subjects With

Status Completed

Clinical Trial Summary

The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.

Clinical Trial Description

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AAV on background cyclophosphamide or rituximab treatment. The primary efficacy objective is to evaluate the efficacy of CCX168 based on the Birmingham Vasculitis Activity Score (BVAS) version 3. The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters. ;

Study Design

Related Conditions & MeSH terms

Vasculitis

Clinical Trial Details

NCT number	NCT01363388
Study type	Interventional
Source	ChemoCentryx
Contact
Status	Completed
Phase	Phase 2
Start date	September 2011
Completion date	January 2016

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A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms