A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
Completed · Phase 3 · Has a placebo group
Conditions studied: ANCA-Associated Vasculitis
In brief
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.
Key facts
- Study ID
- NCT02994927
- Run by
- Amgen
- People needed
- 331
- Starts
- 2017-03-15
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2025-03-24
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis
- Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be enrolled
- Use of adequate contraception
- Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)
- At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS)
- Estimated glomerular filtration rate ≥15 mL/minute/1.73 m\^2 at screening
You may not qualify if…
- Pregnant or breast-feeding
- Alveolar hemorrhage requiring pulmonary ventilation support at screening
- Any other known multi-system autoimmune disease
- Required dialysis or plasma exchange within 12 weeks prior to screening
- Have a kidney transplant
- Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1
- Received intravenous glucocorticoids, >3000 mg methylprednisolone equivalent, within 4 weeks prior to screening
- Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening
- Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count > 0.01x10\^9/L); received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening
- For patients scheduled to receive cyclophosphamide treatment, urinary outflow obstruction, active infection (especially varicella zoster infection), or platelet count <50,000/μL before start of dosing
- Participated previously in a CCX168 study
Where it is running
- Clinical Trial Site — Phoenix, Arizona, United States
- Clinical Trial Site — Phoenix, Arizona, United States
- Clinical Trial Site — Los Angeles, California, United States
- Clinical Trial Site — Santa Monica, California, United States
- Clinical Trial Site — Aurora, Colorado, United States
- Clinical Trial Site — Washington D.C., District of Columbia, United States
- Clinical Trial Site — Daytona Beach, Florida, United States
- Clinical Trial Site — Tampa, Florida, United States
- Clinical Trial Site — Atlanta, Georgia, United States
- Clinical Trial Site — Meridian, Idaho, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — Indianapolis, Indiana, United States
- Clinical Trial Site — Kansas City, Kansas, United States
- Clinical Trial Site — Lexington, Kentucky, United States
- Clinical Trial Site — Shreveport, Louisiana, United States
- Clinical Trial Site — Baltimore, Maryland, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Ann Arbor, Michigan, United States
- Clinical Trial Site — Minneapolis, Minnesota, United States
- Clinical Trial Site — Rochester, Minnesota, United States
- Clinical Trial Site — St Louis, Missouri, United States
- Clinical Trial Site — Great Neck, New York, United States
- Clinical Trial Site — Mineola, New York, United States
- Clinical Trial Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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