Evaluating Avacopan for ANCA-associated Vasculitis
Official title: A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Run by Amgen · NCT06072482 · Data updated 2026-11-12
This study is testing if the medication avacopan is safe for people with ANCA-associated vasculitis who need strong treatments like cyclophosphamide or rituximab.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | rituximab, alemtuzumab, belimumab, tocilizumab, sarilumab, methotrexate, cyclophosphamide, prednisone |
| Locations | 83 sites (Anchorage, Alaska and 82 other locations) |
| Status | Recruiting |
| Started | February 7, 2024 |
| Main results expected | December 31, 2036 |
| Study ends | December 31, 2036 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT06072482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with newly diagnosed or relapsed granulomatosis with polyangiitis or microscopic polyangiitis requiring induction treatment.
✕Probably not a fit
Patients with severe alveolar hemorrhage requiring invasive ventilation support may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the long-term safety of avacopan in patients diagnosed with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Participants will receive either avacopan, a placebo, or standard care as part of their treatment regimen. The study focuses on individuals who require induction treatment with cyclophosphamide or rituximab due to their condition. The evaluation will include monitoring for safety and efficacy over an extended period.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for patients with ANCA-associated vasculitis.
How similar studies have gone: Previous studies have shown promising results with avacopan in treating ANCA-associated vasculitis, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. Note: For participants receiving azathioprine, mycophenolate, or methotrexate, these medications must be discontinued prior to initiation of induction treatment. Participants receiving, or planned to receive combined rituximab and cyclophosphamide for remission induction of the current disease episode at the time of enrollment are not eligible. * 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. * Any other known multisystem autoimmune disease that may confound study assessments and study conclusions including but not limited to eosinophilic granulomatosis with polyangiitis (GPA \[Churg-Strauss\]), systemic lupus erythematosus, immunoglobulin (Ig) A vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis. * Any other medical condition requiring or expected to require continued use of immunosuppressive therapies, including corticosteroids that may cause confoundment with study assessments and study conclusions. * Received dialysis or plasma exchange within 16 weeks before Day 1 randomization. * Have had a kidney transplant. * Malignancy (except curatively treated nonmelanoma skin cancers, curatively treated cervical carcinoma in situ, or breast ductal carcinoma in situ) within the last 5 years before Day 1 randomization. * Acute or chronic, active hepatitis B virus or hepatitis C virus, or human immunodeficiency virus infection during screening. * Any known exposure to a case of active tuberculosis (TB) within the last 12 weeks before Day 1 randomization. * Positive test for active or latent TB during screening. * White blood cell count \< 3500/µL, neutrophil count \< 1500/µL, or lymphocyte count \< 500/µl. Note: Complete Blood Count can be repeated once in the screening period at the investigator discretion. In such instances, eligibility will be determined based on the repeat complete blood count. * Evidence of clinically significant hepatic disease including prior diagnosis of cirrhosis. * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) \>2.0 times the upper limit of normal (ULN). * Total bilirubin \> 1.5 times the ULN. Note: A participant with documented Gilbert's syndrome with total bilirubin \< 2 x ULN may be eligible. * Any of the following within 6 weeks prior to Day 1 randomization: serious infection, infection requiring treatment with intravenous (IV) anti-infective agents, any other infection (including active infection, chronic infection, opportunistic infection, or history of recurrent infection) that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. Oral or vaginal candidiasis and cutaneous or nail fungal infections that are not serious do not constitute an exclusion. * Any of the following within 12 weeks prior to Day 1 randomization: myocardial infarction, stroke, unstable angina, symptomatic congestive heart failure requiring prescription medication, any other clinically significant cardiovascular disease that in the opinion of the investigator would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. * Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent; if on azathioprine (AZA), mycophenolate, or methotrexate (MTX) at the time of screening, these drugs must be withdrawn before receiving CYC. Note: If induction therapy with CYC was started within 2 weeks before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or microscopic polyangiitis (MPA), the participant may be eligible, provided no CYC was received within 12 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with CYC. * Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone equivalent for more than 6 weeks continuously before signing of the informed consent. * Received RTX or other B-cell depleting therapies within 26 weeks before signing of the informed consent; if on AZA, mycophenolate, or MTX at the time of screening, these drugs must be withdrawn before receiving rituximab (RTX). Note: If induction therapy with RTX was started within 2 weeks before signing the informed consent for the current episode of newly diagnosed or relapse of GPA or MPA, the participant may be eligible, provided no RTX was received within 26 weeks before the start of the current induction therapy and if on AZA, mycophenolate, or MTX, these were withdrawn prior to receiving the current induction therapy with RTX. * Received any of the following within 16 weeks before Day 1 randomization: * antitumor necrosis factor treatment * abatacept * alemtuzumab * IV Ig * belimumab * anti interleukin-6 agent (eg, tocilizumab, sarilumab). * Taking a strong or moderate inducer of the cytochrome P450 3A4 (CYP3A4) enzyme unless the strong or moderate CYP3A4 inducer can be changed to an alternative medicine at least 1 week before Day 1 randomization. * Received an investigational drug within 30 days or within 5 half-lives (whichever is longer) before Day 1 randomization. * Previously received avacopan without clinical benefit per the Investigator's opinion or received avacopan within 60 days before Day 1 randomization.
Where it's running
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Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, United States Recruiting -
Southwest Kidney Institute
Surprise, Arizona, United States Recruiting -
Unity Health
Searcy, Arkansas, United States Recruiting -
Palo Alto Medical Foundation Fremont
Fremont, California, United States Recruiting -
The Nephrology Group
Fresno, California, United States Recruiting -
Providence Medical Foundation
Fullerton, California, United States Recruiting
Show 44 more locations
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Southland Arthritis and Osteoarthritis Medical Center, Inc
Menifee, California, United States Recruiting -
University of California San Francisco- Zuckerburg San Francisco General
San Francisco, California, United States Recruiting -
Harbor University of California at Los Angeles Medical Center
Torrance, California, United States Recruiting -
Amicis Research Center
Valencia, California, United States Recruiting -
University of Colorado
Aurora, Colorado, United States Recruiting -
Florida Kidney Physicians
Boca Raton, Florida, United States Recruiting -
Malcom Randall Veterans Affairs Medical Center
Gainesville, Florida, United States Recruiting -
Mayo Clinic
Jacksonville, Florida, United States Recruiting -
ClinTrial Research Oakwater, Llc
Orlando, Florida, United States Recruiting -
University of South Florida
Tampa, Florida, United States Recruiting -
Emory University
Atlanta, Georgia, United States Recruiting -
Lake Cumberland Rheumatology
New Albany, Indiana, United States Recruiting -
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States Recruiting -
Dunes Clinical Research LLC
Sioux City, Iowa, United States Recruiting -
University of Kentucky
Lexington, Kentucky, United States Recruiting -
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Womens Hospital
Boston, Massachusetts, United States Recruiting -
Henry Ford Health System
Detroit, Michigan, United States Recruiting -
Kidney Michigan Institute
Saginaw, Michigan, United States Recruiting -
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, United States Recruiting -
Revive Research Institute
Sterling Heights, Michigan, United States Recruiting -
University of Minnesota
Minneapolis, Minnesota, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
Renown Rheumatology
Reno, Nevada, United States Recruiting -
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting -
Renal Medicine Associates
Albuquerque, New Mexico, United States Recruiting -
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, United States Recruiting -
Northwell Health
Great Neck, New York, United States Recruiting -
Hospital For Special Surgery
New York, New York, United States Recruiting -
Carolina Kidney Associates
Greensboro, North Carolina, United States Recruiting -
East Carolina University Brody Outpatient Center
Greenville, North Carolina, United States Recruiting -
Brookview Hills Research Associates Llc
Winston-Salem, North Carolina, United States Recruiting -
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting -
The Ohio State University
Columbus, Ohio, United States Recruiting -
Stat Research
Miamisburg, Ohio, United States Recruiting -
Hightower Clinical
Oklahoma City, Oklahoma, United States Recruiting -
Oregon Health and Science University
Portland, Oregon, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, United States Recruiting -
Nephrology Associates Inc
East Providence, Rhode Island, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting -
Carolina Nephrology PA
Spartanburg, South Carolina, United States Recruiting
+33 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.