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.
✓ Note: For participants receiving azathioprine, mycophenolate, or methotrexate, these medications must be discontinued prior to initiation of induction treatment. Participants receiving, or planned to receive combined rituximab and cyclophosphamide for remission induction of the current disease episode at the time of enrollment are not eligible.
✓ 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.