A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAmgen
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Avacopan
- Placebo
- Standard of Care
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov