A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Amgen

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

Age range: 18–100 years
Sex: All
Healthy volunteers: No

Detailed 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…

A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Summary

Eligibility

Interventions

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