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.

Description

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

Conditions

Vasculitis

Study Overview

Study Details

Study overview

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

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.

Condition
Vasculitis
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Riley Hospital for Children, Indianapolis, Indiana, United States, 46202

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

Akron

Akron Childrens Hospital, Akron, Ohio, United States, 44308

Houston

Texas Childrens Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2030-07-20