NCT01363388

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

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: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

• Vasculitis

Interventions

Type	Name	Description
DRUG	Placebo	BID for 84 days
DRUG	CCX168	BID for 84 days

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2011-06-01
• Last updated: 2025-03-13
• Results posted: 2020-07-27

Locations

44 sites across 10 countries: Austria, Belgium, Czechia, France, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom