RecruitingAntineutrophil Cytoplasmic Antibody-associated Vasculitis

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

Eligible age

18–100 yrs

Accepts

All genders

Locations

31 states

Healthy volunteers

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About this study

The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

Sponsor: Amgen

You may qualify if…

✓ Participants has provided informed consent before initiation of any study-specific activities/procedures.
✓ Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed.
✓ Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years).
✓ Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.
✓ At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
✓ eGFR \>/= 15 mL/min/1.73 m\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).

You may not qualify if…

✕ Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.
✕ Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA \[Churg-Strauss\]), systemic lupus erythematosus, immunoglobulin (Ig) A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.
✕ Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions.
✕ Received dialysis or plasma exchange within 16 weeks before Day 1 randomization.
✕ Have had a kidney transplant.
✕ Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ) within the last 5 years before Day 1 randomization.
✕ Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening.
✕ Any known exposure to a case of active tuberculosis (TB) within the last 12 weeks before Day 1 randomization.