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Pediatric avacopan with rituximab or cyclophosphamide for active ANCA-associated vasculitis
2024-514779-16-00Phase 3Authorised
- Sponsor
- Amgen
- Start
- Feb 2025
- Modality
- Small Molecules
- Countries
- 10
01
Overview
Phase 3, open-label, single-arm trial of avacopan in anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), sponsored by Amgen. Primary endpoints: Disease remission at week 26 based on PVAS, Sustained remission at week 52 based on PVAS and 1 more. Planned start Feb 2025; status: authorised.
02
Drugs
avacopan
03
Conditions
anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV)granulomatosis with polyangiitis (GPA)microscopic polyangiitis (MPA)
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