CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids +2 moredrug
Likely dose
CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoidsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02222155
NCT02222155Phase 2Completed
CompareCT.gov

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

Amgen·interventional·Posted Aug 21, 2014·Updated Mar 13, 2025

In Brief

A Phase 2 clinical trial evaluating CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids, CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids, and 1 other intervention for ANCA-associated Vasculitis. Completed, enrolled 42 participants across 43 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsANCA-associated Vasculitis
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 21, 2014
Enrollment StartFeb 4, 2015
Primary CompletionApr 24, 2016
Study CompletionJul 19, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago

Interventions

CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoidsdrug

CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoidsdrug

Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoidsother