NCT02222155

Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis

A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Funding Source - FDA OOPD

Detailed description

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 2 study to evaluate the safety and efficacy of the C5aR inhibitor CCX168 in subjects with ANCA-associated vasculitis. The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

• ANCA-associated Vasculitis

Interventions

Type	Name	Description
DRUG	CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
DRUG	CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
OTHER	Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids

Timeline

• Start date: 2015-02-04
• Primary completion: 2016-04-24
• Completion: 2016-07-19
• First posted: 2014-08-21
• Last updated: 2025-03-13
• Results posted: 2023-08-16

Locations

43 sites across 2 countries: United States, Canada