Recruiting

Avacopan

Sponsor:

Amgen

Code:

NCT06072482

Conditions

Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Avacopan

Placebo

Standard of Care

Study Details

Brief 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).

Conditions

Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Study ID

NCT06072482

Start date

Feb 7, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2036

Anticipated

Primary completion date

Dec 31, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.
  • 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 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 1 week 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 1 week 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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A: Avacopan + Standard of Care (SoC)

Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.

experimental: Group B: Avacopan/Placebo + SoC

Avacopan 30 mg twice daily for 1 year, followed by placebo twice daily for 4 years + SoC background immunosuppressive therapy.

placebo comparator: Group C: Placebo + SoC

Placebo twice daily for 5 years + SoC background immunosuppressive therapy.

Interventions

Avacopan

Administered orally.

Placebo

Administered orally.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Scottsdale Healthcare at Shea - HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Southwest Kidney Institute

Recruiting

Surprise, Arizona, United States, 85374

Unity Health

Recruiting

Searcy, Arkansas, United States, 72143

Palo Alto Medical Foundation Fremont

Recruiting

Fremont, California, United States, 94538

The Nephrology Group

Recruiting

Fresno, California, United States, 93720

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Southland Arthritis and Osteoarthritis Medical Center, Inc

Recruiting

Menifee, California, United States, 92586

University of California San Francisco- Zuckerburg San Francisco General

Recruiting

San Francisco, California, United States, 94110

Harbor University of California at Los Angeles Medical Center

Recruiting

Torrance, California, United States, 90502

Amicis Research Center

Recruiting

Valencia, California, United States, 91355

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Florida Kidney Physicians

Recruiting

Boca Raton, Florida, United States, 33431

Malcom Randall Veterans Affairs Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

ClinTrial Research Oakwater, Llc

Recruiting

Orlando, Florida, United States, 32806

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Lake Cumberland Rheumatology

Recruiting

New Albany, Indiana, United States, 47150

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Dunes Clinical Research LLC

Recruiting

Sioux City, Iowa, United States, 51104

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Kidney Michigan Institute

Recruiting

Saginaw, Michigan, United States, 49804

Clinical Research Institute of Michigan

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Revive Research Institute

Recruiting

Sterling Heights, Michigan, United States, 48313

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Renown Rheumatology

Recruiting

Reno, Nevada, United States, 89502

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Renal Medicine Associates

Recruiting

Albuquerque, New Mexico, United States, 87109

New York Nephrology Vasculitis and Glomerular Center

Recruiting

Albany, New York, United States, 12209

Northwell Health

Recruiting

Great Neck, New York, United States, 11021

Hospital For Special Surgery

Recruiting

New York, New York, United States, 10021

Carolina Kidney Associates

Recruiting

Greensboro, North Carolina, United States, 27405

East Carolina University Brody Outpatient Center

Recruiting

Greenville, North Carolina, United States, 27834

Brookview Hills Research Associates Llc

Recruiting

Winston-Salem, North Carolina, United States, 27103

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43201

Stat Research

Recruiting

Miamisburg, Ohio, United States, 45342

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73114

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Allegheny Health Network Cancer Institute at Mellon Pavilion

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Nephrology Associates Inc

Recruiting

East Providence, Rhode Island, United States, 02914

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Carolina Nephrology PA

Recruiting

Spartanburg, South Carolina, United States, 29306

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Vital Rheumatology

Recruiting

Austin, Texas, United States, 78727

Renal Disease Research Institute - Landry Office

Recruiting

Dallas, Texas, United States, 75204

Epic Medical Research - Red Oak

Recruiting

Red Oak, Texas, United States, 75154

Scott and White Memorial Hospital

Recruiting

Temple, Texas, United States, 76502

Nephrology Associates of Northern Virginia Inc

Recruiting

Fairfax, Virginia, United States, 22033

Rheumatology and Pulmonary Clinic

Recruiting

Beckley, West Virginia, United States, 25801

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Amgen

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Avacopan
  • ANCA-associated Vasculitis
  • AAV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-14.