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.

Amgen

Status and phase

Enrolling

Phase 3

Conditions

Vasculitis

Treatments

Drug: Avacopan

Study type

Interventional

Funder types

Industry

Identifiers

20230070

Details and patient eligibility

About

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.

Enrollment

20 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.