RECRUITING

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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Conditions

VasculitisPediatricAvacopanTavneos®

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2024-10-22
Study Completion:2030-07-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06321601

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.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male and female children and adolescents from 6 to \< 18 years of age
  2. * Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013)
  3. * Newly diagnosed or relapsed AAV with positive test for anti-PR3 or anti-MPO antibodies
  4. * At least 1 PVAS major item, at least 3 PVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
  5. * eGFR \> 15 mL/min/1.73 m2 (using modified Schwartz equation per central lab guidelines)
  6. * Participants must have a bodyweight of ≥ 15 kg at day 1.
  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
  2. * Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
  3. * 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.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Akron Childrens Hospital
Akron, Ohio, 44308
United States
Texas Childrens Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22
Study Completion Date2030-07-20

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2030-07-20

Terms related to this study

Keywords Provided by Researchers

  • Pediatric
  • Avacopan
  • Tavneos®

Additional Relevant MeSH Terms

  • Vasculitis