NCT06072482 · Amgen
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
What this study is about
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
View original scientific description
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Interventions
DRUG
Avacopan
Administered orally.
DRUG
Placebo
Administered orally.
DRUG
Standard of Care
All participants will receive SoC background immunosuppressive therapy for induction and maintenance, at the discretion of the Investigator and as supported by current guidelines, product labels and local practices and informed by the individual participant's clinical condition, preferences, and values.
Primary outcome measures
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Month 60
Percentage of Participants Experiencing Adverse Events of Special Interest
Time frame: Up to Month 60
Percentage of Participants Experiencing Serious Adverse Events
Time frame: Up to Month 60
Percentage of Participants Experiencing Adverse Events Leading to Withdrawal
Time frame: Up to Month 60
Percentage of Participants Experiencing Adverse Events Leading to Death
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments
Time frame: Up to Month 60
Number of Participants Experiencing Clinical Significant Changes from Baseline in Urinalysis Assessments
Time frame: Up to Month 60
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
- Participants has provided informed consent before initiation of any study-specific activities/procedures.
- Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed.
- Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years).
- Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies.
- At least 1 Birmingham Vasculitis Activity Score (BVAS) major item, or at least 3 BVAS nonmajor items, or at least the 2 renal items of proteinuria and hematuria.
- eGFR \>/= 15 mL/min/1.73 m\^2 (using Chronic Kidney Disease Epidemiology Collaboration equations).
Exclusion criteria
- Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.
Where
- Anchorage, Alaska
- Scottsdale, Arizona
- Surprise, Arizona
- Searcy, Arkansas
- Covina, California
- Fremont, California
- Fresno, California
- Fullerton, California
- Menifee, California
- San Francisco, California
- Torrance, California
- Aurora, Colorado
And 47 more locations — see the full list below.
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