NCT06321601 · Amgen
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.
What this study is about
The main objective of this study is to explore the effectiveness of avacopan in participants affected by AAV.
View original scientific description
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
Interventions
DRUG
Avacopan
Oral administration
Primary outcome measures
Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS)
Time frame: Week 26
Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS
Time frame: Week 52
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 invasi
Where
- Atlanta, Georgia
- Indianapolis, Indiana
- Minneapolis, Minnesota
- Lake Success, New York
- Chapel Hill, North Carolina
- Charlotte, North Carolina
- Akron, Ohio
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations