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

NCT02222155 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-03-13

Study results available
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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

Conditions

  • ANCA-associated Vasculitis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-04
Primary Completion
2016-04-24
Completion
2016-07-19

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02222155 on ClinicalTrials.gov