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Recruiting Phase 4 NCT06072482

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

Trial Parameters

Condition Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Sponsor Amgen
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2024-02-07
Completion 2036-12-31
Interventions
AvacopanPlaceboStandard of Care

Brief Summary

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).

Eligibility Criteria

Inclusion Criteria: * 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). Exclusion Criteria: * Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study. * Any

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