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NCT02222155 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of ANCA-Associated Vasculitis, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
42
Enrollment target
20
Study locations

NCT02222155 is a Phase 2 study of ANCA-Associated Vasculitis that has completed, run by Amgen. The registered enrollment target is 42 participants, below the 1,363-participant average among 3 other ANCA-Associated Vasculitis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT02222155, a Phase 2 study of ANCA-Associated Vasculitis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
42 participants
Enrollment target
20
Study locations

Study 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 Studied

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

Study Locations (20)

California

  • - Long Beach
  • - Los Angeles
  • - San Francisco

Arizona

  • - Phoenix
  • - Tucson

Florida

  • - Miami Springs
  • - Tampa

Kentucky

  • - Lexington
  • - Louisville

Alabama

  • - Huntsville

Colorado

  • - Aurora

District of Columbia

  • - Washington D.C.

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2015-02-04
Est. Completion 2016-07-19
Phase Phase 2

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT02222155

The ClinicalTrials.gov registry entry for NCT02222155 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,363-participant average among 3 other ANCA-Associated Vasculitis trials with a reported enrollment target (97% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with ANCA-Associated Vasculitis appearing as the primary indexed condition, and to 3 interventions - of which CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids is the first listed.

NCT02222155 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT02222155 about?

NCT02222155 is a clinical study titled "Clinical Trial to Evaluate Safety and Efficacy of CCX168 in 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). Funding Source - FDA OOPD

What is the current status of trial NCT02222155?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-02-04. Estimated completion is 2016-07-19.

What conditions does trial NCT02222155 study?

This clinical trial studies the following conditions: ANCA-Associated Vasculitis.

What interventions are being tested in trial NCT02222155?

The interventions under investigation include: CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids (DRUG), CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids (DRUG), Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids (OTHER).

Who is sponsoring clinical trial NCT02222155?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02222155 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.