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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.

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Amgen

Status and phase

Enrolling
Phase 3

Conditions

Vasculitis

Treatments

Drug: Avacopan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06321601
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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Avacopan
Experimental group
Description:
Participants will receive avacopan twice-daily (BID) administered as oral tablets or liquid formula for 52 weeks.
Treatment:
Drug: Avacopan

Trial contacts and locations

4

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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