RecruitingPhase 3NCT06321601
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
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)
Sponsor
Amgen
Enrollment
20 participants
Start Date
Oct 22, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Eligibility
Min Age: 6 YearsMax Age: 17 Years
Inclusion Criteria6
- Male and female children and adolescents from 6 to \< 18 years of age
- Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013)
- Newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
- At least 1 PVAS major item, at least 3 PVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
- eGFR \> 15 mL/min/1.73 m2 (using modified Schwartz equation per central lab guidelines)
- Participants must have a bodyweight of ≥ 15 kg at day 1.
Exclusion Criteria3
- Any other known multisystem autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus , IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
- Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
- Any medical condition requiring or expected to require continued use of immunosuppressive treatments, including corticosteroids that may cause confoundment with study assessments and study conclusions.
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Interventions
DRUGAvacopan
Oral administration
Locations(30)
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NCT06321601
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