A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
NCT ID: NCT06072482
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2024-02-07
2036-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Avacopan + Standard of Care (SoC)
Avacopan 30 mg twice daily for 5 years + SoC background immunosuppressive therapy.
Avacopan
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.
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.
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.
Group C: Placebo + SoC
Placebo twice daily for 5 years + SoC background immunosuppressive therapy.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Orthopedic Physicians Alaska
Anchorage, Alaska, United States
Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, United States
Southwest Kidney Institute
Surprise, Arizona, United States
Medvin Clinical Research
Covina, California, United States
Palo Alto Medical Foundation Fremont
Fremont, California, United States
The Nephrology Group
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Medvin Clinical Research
Menifee, California, United States
University of California San Francisco- Zuckerburg San Francisco General
San Francisco, California, United States
Harbor University of California at Los Angeles Medical Center
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Florida Kidney Physicians
Boca Raton, Florida, United States
Malcom Randall Veterans Affairs Medical Center
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
ClinTrial Research Oakwater, Llc
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Lake Cumberland Rheumatology
New Albany, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Dunes Clinical Research LLC
Sioux City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Kidney Michigan Institute
Saginaw, Michigan, United States
Revive Research Institute
Sterling Heights, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Renown Rheumatology
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, United States
Northwell Health
Great Neck, New York, United States
Hospital For Special Surgery
New York, New York, United States
East Carolina University Brody Outpatient Center
Greenville, North Carolina, United States
Brookview Hills Research Associates Llc
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Stat Research
Miamisburg, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Nephrology Associates Inc
East Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Renal Disease Research Institute - Landry Office
Dallas, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Revmatologicky ustav
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Spzoz Centralny Szpital Kliniczny Umed w Lodzi
Lodz, , Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, , Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy Centralny Szpital Kliniczny Mon
Warsaw, , Poland
Spitalul Clinic Sf Maria, Bucuresti
Bucharest, , Romania
Spitalul Clinic Dr Ion Cantacuzino
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, , Romania
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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EU CT Number
Identifier Type: OTHER
Identifier Source: secondary_id
20220159
Identifier Type: -
Identifier Source: org_study_id
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