A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis (NCT06072482) | Clinical Trial Compass
RecruitingPhase 4
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
United States300 participantsStarted 2024-02-07
Plain-language 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).
Who can participate
Age range18 Years – 100 Years
SexALL
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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 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 immunosuppressi…
What they're measuring
1
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Month 60
2
Percentage of Participants Experiencing Adverse Events of Special Interest
Timeframe: Up to Month 60
3
Percentage of Participants Experiencing Serious Adverse Events
Timeframe: Up to Month 60
4
Percentage of Participants Experiencing Adverse Events Leading to Withdrawal
Timeframe: Up to Month 60
5
Percentage of Participants Experiencing Adverse Events Leading to Death
Timeframe: Up to Month 60
6
Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements
Timeframe: Up to Month 60
7
Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments
Timeframe: Up to Month 60
8
Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments