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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: Completed Phase 2 study of ANCA-Associated Vasculitis, sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-02-04 |
| Est. Completion | 2016-07-19 |
| Phase | Phase 2 |
What the finished NCT02222155 record still lists
NCT02222155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,363-participant average among 3 other ANCA-Associated Vasculitis trials with a reported enrollment target (97% lower).
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 names 20 study sites across 15 states, led by 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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