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New drug avacopan under Long-Term safety review for vasculitis patients

NCT ID NCT06072482

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study is checking the long-term safety of a drug called avacopan for people with ANCA-associated vasculitis, a rare disease where the immune system attacks blood vessels. About 300 adults who need treatment for a new diagnosis or flare-up will take avacopan or a placebo. The main goal is to see what side effects occur over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis granulomatosis with polyangiitis microscopic polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antineutrophil cytoplasmic antibody-associated vasculitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aalborg Universitetshospital

    ACTIVE_NOT_RECRUITING

    Aalborg, 9000, Denmark

  • Allegheny Health Network Cancer Institute at Mellon Pavilion

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Amicis Research Center

    RECRUITING

    Valencia, California, 91355, United States

  • Brigham and Womens Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brookview Hills Research Associates Llc

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Carolina Kidney Associates

    RECRUITING

    Greensboro, North Carolina, 27405, United States

  • Carolina Nephrology PA

    RECRUITING

    Spartanburg, South Carolina, 29306, United States

  • ClinTrial Research Oakwater, Llc

    RECRUITING

    Orlando, Florida, 32806, United States

  • Clinical Research Institute of Michigan

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Debreceni Egyetem Klinikai Kozpont

    ACTIVE_NOT_RECRUITING

    Debrecen, 4032, Hungary

  • Dunes Clinical Research LLC

    RECRUITING

    Sioux City, Iowa, 51104, United States

  • East Carolina University Brody Outpatient Center

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Epic Medical Research - Red Oak

    RECRUITING

    Red Oak, Texas, 75154, United States

  • Fakultni nemocnice Hradec Kralove

    ACTIVE_NOT_RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    ACTIVE_NOT_RECRUITING

    Prague, 100 34, Czechia

  • Fakultni nemocnice Olomouc

    ACTIVE_NOT_RECRUITING

    Olomouc, 779 00, Czechia

  • Fakultni nemocnice Ostrava

    ACTIVE_NOT_RECRUITING

    Ostrava - Poruba, 708 52, Czechia

  • Fakultni nemocnice Plzen

    ACTIVE_NOT_RECRUITING

    Pilsen, 304 60, Czechia

  • Florida Kidney Physicians

    RECRUITING

    Boca Raton, Florida, 33431, United States

  • General Hospital of Athens Laiko

    ACTIVE_NOT_RECRUITING

    Athens, 11527, Greece

  • Harbor University of California at Los Angeles Medical Center

    RECRUITING

    Torrance, California, 90502, United States

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hightower Clinical

    RECRUITING

    Oklahoma City, Oklahoma, 73114, United States

  • Hippokration General Hospital of Athens

    ACTIVE_NOT_RECRUITING

    Athens, 11527, Greece

  • Hospital For Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • Johns Hopkins Bayview Medical Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Kidney Michigan Institute

    RECRUITING

    Saginaw, Michigan, 49804, United States

  • Lake Cumberland Rheumatology

    RECRUITING

    New Albany, Indiana, 47150, United States

  • Malcom Randall Veterans Affairs Medical Center

    RECRUITING

    Gainesville, Florida, 32608, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medvin Clinical Research

    TERMINATED

    Covina, California, 91722, United States

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

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-637, Poland

  • Nephrology Associates Inc

    RECRUITING

    East Providence, Rhode Island, 02914, United States

  • Nephrology Associates of Northern Virginia Inc

    RECRUITING

    Fairfax, Virginia, 22033, United States

  • New York Nephrology Vasculitis and Glomerular Center

    RECRUITING

    Albany, New York, 12209, United States

  • Northwell Health

    RECRUITING

    Great Neck, New York, 11021, United States

  • Odense Universitetshospital

    ACTIVE_NOT_RECRUITING

    Odense C, 5000, Denmark

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Orthopedic Physicians Alaska

    TERMINATED

    Anchorage, Alaska, 99508, United States

  • Palo Alto Medical Foundation Fremont

    RECRUITING

    Fremont, California, 94538, United States

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    ACTIVE_NOT_RECRUITING

    Pécs, 7632, Hungary

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Renal Disease Research Institute - Landry Office

    RECRUITING

    Dallas, Texas, 75204, United States

  • Renal Medicine Associates

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Renown Rheumatology

    RECRUITING

    Reno, Nevada, 89502, United States

  • Revive Research Institute

    RECRUITING

    Sterling Heights, Michigan, 48313, United States

  • Revmatologicky ustav

    ACTIVE_NOT_RECRUITING

    Prague, 128 00, Czechia

  • Rheumatology and Pulmonary Clinic

    RECRUITING

    Beckley, West Virginia, 25801, United States

  • Rigshospitalet

    ACTIVE_NOT_RECRUITING

    Copenhagen, 2100, Denmark

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

    ACTIVE_NOT_RECRUITING

    Lodz, 90-153, Poland

  • Scott and White Memorial Hospital

    RECRUITING

    Temple, Texas, 76502, United States

  • Scottsdale Healthcare at Shea - HonorHealth

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Southland Arthritis and Osteoarthritis Medical Center, Inc

    RECRUITING

    Menifee, California, 92586, United States

  • Southwest Kidney Institute

    RECRUITING

    Surprise, Arizona, 85374, United States

  • Spitalul Clinic Dr Ion Cantacuzino

    ACTIVE_NOT_RECRUITING

    Bucharest, 020475, Romania

  • Spitalul Clinic Judetean de Urgenta Cluj

    ACTIVE_NOT_RECRUITING

    Cluj-Napoca, 400006, Romania

  • Spitalul Clinic Sf Maria, Bucuresti

    ACTIVE_NOT_RECRUITING

    Bucharest, 011172, Romania

  • Spzoz Centralny Szpital Kliniczny Umed w Lodzi

    ACTIVE_NOT_RECRUITING

    Lodz, 92-213, Poland

  • Stat Research

    RECRUITING

    Miamisburg, Ohio, 45342, United States

  • The Nephrology Group

    RECRUITING

    Fresno, California, 93720, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43201, United States

  • Unity Health

    RECRUITING

    Searcy, Arkansas, 72143, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California San Francisco- Zuckerburg San Francisco General

    RECRUITING

    San Francisco, California, 94110, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55414, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • Vanderbilt University Medical Center

    TERMINATED

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Medical Center

    TERMINATED

    Seattle, Washington, 98101, United States

  • Vital Rheumatology

    RECRUITING

    Austin, Texas, 78727, United States

  • Vseobecna fakultni nemocnice v Praze

    ACTIVE_NOT_RECRUITING

    Prague, 128 08, Czechia

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

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

    ACTIVE_NOT_RECRUITING

    Warsaw, 04-141, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.