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Antineutrophil Cytoplasmic Antibody-associated VasculitisPhase 4AVASETNCT06072482

A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis

A Phase 4 study testing Avacopan in people with Antineutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 83 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Avacopan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
83 sitesin 7 countries
Study dates
7 Feb 2024to 31 Dec 2036
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.

Trial locations and contacts

83 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

83 sites in 7 countries

United States62 sites, 58 recruiting

  • New York Nephrology Vasculitis and Glomerular Center

    Albany, New York, 12209

    Recruiting

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

    Recruiting

  • Orthopedic Physicians Alaska

    Anchorage, Alaska, 99508

    Terminated

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Vital Rheumatology

    Austin, Texas, 78727

    Recruiting

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

    Recruiting

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

    Recruiting

  • Florida Kidney Physicians

    Boca Raton, Florida, 33431

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43201

    Recruiting

  • Medvin Clinical Research

    Covina, California, 91722

    Terminated

  • Renal Disease Research Institute - Landry Office

    Dallas, Texas, 75204

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Recruiting

  • Nephrology Associates Inc

    East Providence, Rhode Island, 02914

    Recruiting

  • Nephrology Associates of Northern Virginia Inc

    Fairfax, Virginia, 22033

    Recruiting

  • Palo Alto Medical Foundation Fremont

    Fremont, California, 94538

    Recruiting

  • The Nephrology Group

    Fresno, California, 93720

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Recruiting

  • Malcom Randall Veterans Affairs Medical Center

    Gainesville, Florida, 32608

    Recruiting

  • Northwell Health

    Great Neck, New York, 11021

    Recruiting

  • Carolina Kidney Associates

    Greensboro, North Carolina, 27405

    Recruiting

  • East Carolina University Brody Outpatient Center

    Greenville, North Carolina, 27834

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Recruiting

  • Southland Arthritis and Osteoarthritis Medical Center, Inc

    Menifee, California, 92586

    Recruiting

  • Stat Research

    Miamisburg, Ohio, 45342

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Terminated

  • Lake Cumberland Rheumatology

    New Albany, Indiana, 47150

    Recruiting

  • Hospital For Special Surgery

    New York, New York, 10021

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73114

    Recruiting

  • ClinTrial Research Oakwater, Llc

    Orlando, Florida, 32806

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Allegheny Health Network Cancer Institute at Mellon Pavilion

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Epic Medical Research - Red Oak

    Red Oak, Texas, 75154

    Recruiting

  • Renown Rheumatology

    Reno, Nevada, 89502

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • Kidney Michigan Institute

    Saginaw, Michigan, 49804

    Recruiting

  • Clinical Research Institute of Michigan

    Saint Clair Shores, Michigan, 48081

    Recruiting

  • University of California San Francisco- Zuckerburg San Francisco General

    San Francisco, California, 94110

    Recruiting

  • Scottsdale Healthcare at Shea - HonorHealth

    Scottsdale, Arizona, 85258

    Recruiting

  • Unity Health

    Searcy, Arkansas, 72143

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Terminated

  • Dunes Clinical Research LLC

    Sioux City, Iowa, 51104

    Recruiting

  • Carolina Nephrology PA

    Spartanburg, South Carolina, 29306

    Recruiting

  • Revive Research Institute

    Sterling Heights, Michigan, 48313

    Recruiting

  • Southwest Kidney Institute

    Surprise, Arizona, 85374

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Recruiting

  • Scott and White Memorial Hospital

    Temple, Texas, 76502

    Recruiting

  • Harbor University of California at Los Angeles Medical Center

    Torrance, California, 90502

    Recruiting

  • Amicis Research Center

    Valencia, California, 91355

    Recruiting

  • Brookview Hills Research Associates Llc

    Winston-Salem, North Carolina, 27103

    Recruiting

Other trials in United States

Czechia7 sites, 7 recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

    Recruiting

  • Fakultni nemocnice Plzen

    Pilsen, 304 60

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

    Recruiting

  • Revmatologicky ustav

    Prague, 128 00

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

    Recruiting

Other trials in Czechia

Poland4 sites, 4 recruiting

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153

    Recruiting

  • Spzoz Centralny Szpital Kliniczny Umed w Lodzi

    Lodz, 92-213

    Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warsaw, 02-637

    Recruiting

  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon

    Warsaw, 04-141

    Recruiting

Other trials in Poland

Denmark3 sites, 3 recruiting

  • Aalborg Universitetshospital

    Aalborg, 9000

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

  • Odense Universitetshospital

    Odense C, 5000

    Recruiting

Other trials in Denmark

Romania3 sites, 3 recruiting

  • Spitalul Clinic Sf Maria, Bucuresti

    Bucharest, 011172

    Recruiting

  • Spitalul Clinic Dr Ion Cantacuzino

    Bucharest, 020475

    Recruiting

  • Spitalul Clinic Judetean de Urgenta Cluj

    Cluj-Napoca, 400006

    Recruiting

Other trials in Romania

Greece2 sites, 2 recruiting

  • General Hospital of Athens Laiko

    Athens, 11527

    Recruiting

  • Hippokration General Hospital of Athens

    Athens, 11527

    Recruiting

Other trials in Greece

Hungary2 sites, 2 recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

    Recruiting

Other trials in Hungary

About this study

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

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).

Being tested
Avacopan, Placebo, Standard of Care
Keywords
Avacopan, ANCA-associated Vasculitis, AAV
Medical subject headings
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvacopanDrug

    Also called CCX168

    Administered orally.

  • PlaceboDrug

    Administered orally.

  • Standard of CareDrug

    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.

Study groups in NCT06072482
Study groupRoleWhat they receive
Group A: Avacopan + Standard of Care (SoC)ExperimentalAvacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.
Receives: Drug: Avacopan; Drug: Standard of Care
Group B: Avacopan/Placebo + SoCExperimentalAvacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.
Receives: Drug: Avacopan; Drug: Placebo; Drug: Standard of Care
Group C: Placebo + SoCPlacebo comparatorPlacebo twice daily for 5 years + SoC background immunosuppressive therapy.
Receives: Drug: Placebo; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to Month 60

  2. Percentage of Participants Experiencing Adverse Events of Special Interest

    Measured: Up to Month 60

  3. Percentage of Participants Experiencing Serious Adverse Events

    Measured: Up to Month 60

  4. Percentage of Participants Experiencing Adverse Events Leading to Withdrawal

    Measured: Up to Month 60

  5. Percentage of Participants Experiencing Adverse Events Leading to Death

    Measured: Up to Month 60

  6. Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements

    Measured: Up to Month 60

  7. Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments

    Measured: Up to Month 60

  8. Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments

    Measured: Up to Month 60

  9. Number of Participants Experiencing Clinical Significant Changes from Baseline in Urinalysis Assessments

    Measured: Up to Month 60

Secondary outcomes (11)

  1. Group A and B Participants who Achieved Remission at Month 12: Time to Relapse in AAV Between Month 12 and Month 60

    Measured: Month 12 to Month 60

  2. Group A and B Participants who Achieved Remission at Month 12: Percentage of Participants who Relapse After Achieving Remission at Month 12

    Measured: Month 12 to Month 60

  3. Groups A and C: Percentage of Participants who Achieved Sustained Remission at Month 60

    Measured: Month 60

  4. Group A and C Participants with Overt Renal Disease at Baseline: Change from Baseline to Month 60 in Estimated Glomerular Filtration Rate (eGFR)

    Measured: Baseline and Month 60

  5. Groups A and C: Change from Baseline to Month 60 in Short Form 36 Health Survey Version 2 (SF-36 v2) General Health Perception Score

    Measured: Baseline and Month 60

  6. Groups A and C: Change from Baseline to Month 60 in EuroQoL-5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)

    Measured: Baseline and Month 60

  7. Percentage of Participants who Achieved Remission at Month 6

    Measured: Month 6

  8. Groups A and C: Change from Baseline to Month 60 in Vasculitis Damage Index (VDI)

    Measured: Baseline and Month 60

  9. Groups A and C: Percentage of Participants with Composite Outcome of Initiation of Maintenance Dialysis, Kidney Transplantation, or Death

    Measured: Up to Month 60

  10. Percentage of Participants With Glucocorticoid Use

    Measured: Up to Month 60

  11. Percentage of Participants With Immunosuppressant Use

    Measured: Up to Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start7 Feb 2024
  3. Primary completion31 Dec 2036 (estimated)
  4. Study completion31 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072482
Sponsor's protocol ID
20220159
Other IDs
EU CT Number
Acronym
AVASET
Status last verified
Sep 2026
First submitted
2 Oct 2023
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Avacopan in people with Antineutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 83 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Czechia, Poland, Denmark, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Month 60). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06072482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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