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.

Launched by AMGEN · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called avacopan to see how well it works when used with treatments like rituximab or cyclophosphamide in children aged 6 to 17 who have a specific type of blood vessel inflammation called ANCA-associated vasculitis (AAV). The main goal is to find out if avacopan can help improve the health of children who are newly diagnosed or experiencing a relapse of this condition.

To participate in this study, children must be between 6 and 17 years old and have a confirmed diagnosis of either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). They should also have certain symptoms that indicate their condition is affecting their kidneys or other organs. It's important to note that children with other autoimmune diseases or those needing specific ongoing treatments may not be eligible. Participants can expect to receive close monitoring throughout the trial to ensure their safety and to assess how well the treatment is working. This study is currently recruiting participants, so it’s a great opportunity for eligible families looking for new treatment options.

Gender

ALL

Eligibility criteria

• 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.