A Phase 3 Study of Avacopan in Active ANCA-associated Vasculitis (AAV)
Research type
Research Study
Full title
A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children from 6 Years to <18 Years of Age with Active ANCA-associated Vasculitis (AAV)
IRAS ID
1011286
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2024-514779-16
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about avacopan in participants aged 6 years to less than 18 years with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV; a rare disease where the body’s immune system mistakenly attacks small to medium sized blood vessels, causing them to become inflamed and damaged). AAV includes different subtypes. This study focuses on two subtypes of AAV: granulomatosis with polyangiitis (GPA), which mainly affects the respiratory system and kidneys among other organs and microscopic polyangiitis (MPA), which primarily affects the kidneys among other organs.
This study will explore if avacopan combined with rituximab or cyclophosphamide containing regimen (a planned regular treatment) works well to treat AAV. This study will also look at how avacopan moves throughout the body and whether avacopan is safe to take. Avacopan, rituximab or cyclophosphamide that will be received as part of this study will be called study product.
Patients who participate in the study will undergo a screening period of up to 30 days. The main study period will last for about 60 weeks, which includes treatment period of about 52 weeks, and safety follow-up of about 8 weeks after the patient receives the last dose of avacopan.REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0127
Date of REC Opinion
8 Dec 2025
REC opinion
Further Information Favourable Opinion