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

RecruitingPhase 4

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

Who can join

Ages 18 to 100 · All sexes

Full eligibility 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.
* 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.

About the study

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).

What is being tested

Sponsor: Amgen · Participants: 300 · Started: Feb 7, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06072482

Locations in the U.S.

ArizonaScottsdale Healthcare at Shea - HonorHealth, Scottsdale
Southwest Kidney Institute, Surprise
ArkansasUnity Health, Searcy
CaliforniaPalo Alto Medical Foundation Fremont, Fremont
The Nephrology Group, Fresno
Providence Medical Foundation, Fullerton
Southland Arthritis and Osteoarthritis Medical Center, Inc, Menifee
University of California San Francisco- Zuckerburg San Francisco General, San Francisco
Harbor University of California at Los Angeles Medical Center, Torrance
Amicis Research Center, Valencia
ColoradoUniversity of Colorado, Aurora
FloridaFlorida Kidney Physicians, Boca Raton
Malcom Randall Veterans Affairs Medical Center, Gainesville
Mayo Clinic, Jacksonville
ClinTrial Research Oakwater, Llc, Orlando
University of South Florida, Tampa
GeorgiaEmory University, Atlanta
IndianaLake Cumberland Rheumatology, New Albany
IowaUniversity of Iowa Hospitals and Clinics, Iowa City
Dunes Clinical Research LLC, Sioux City
KentuckyUniversity of Kentucky, Lexington
MarylandJohns Hopkins Bayview Medical Center, Baltimore
MassachusettsBrigham and Womens Hospital, Boston
Massachusetts General Hospital, Boston
MichiganHenry Ford Health System, Detroit
Kidney Michigan Institute, Saginaw
Clinical Research Institute of Michigan, Saint Clair Shores
Revive Research Institute, Sterling Heights
MinnesotaUniversity of Minnesota, Minneapolis
Mayo Clinic, Rochester
NevadaRenown Rheumatology, Reno
New HampshireDartmouth Hitchcock Medical Center, Lebanon
New MexicoRenal Medicine Associates, Albuquerque
New YorkNew York Nephrology Vasculitis and Glomerular Center, Albany
Northwell Health, Great Neck
Hospital For Special Surgery, New York
North CarolinaCarolina Kidney Associates, Greensboro
East Carolina University Brody Outpatient Center, Greenville
Brookview Hills Research Associates Llc, Winston-Salem
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
The Ohio State University, Columbus
Stat Research, Miamisburg
OklahomaHightower Clinical, Oklahoma City
OregonOregon Health and Science University, Portland
PennsylvaniaUniversity of Pennsylvania, Philadelphia
Allegheny Health Network Cancer Institute at Mellon Pavilion, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
Rhode IslandNephrology Associates Inc, East Providence
South CarolinaMedical University of South Carolina, Charleston
Carolina Nephrology PA, Spartanburg
TennesseeWest Tennessee Research Institute, Jackson
TexasVital Rheumatology, Austin
Renal Disease Research Institute - Landry Office, Dallas
Epic Medical Research - Red Oak, Red Oak
Scott and White Memorial Hospital, Temple
VirginiaNephrology Associates of Northern Virginia Inc, Fairfax
West VirginiaRheumatology and Pulmonary Clinic, Beckley
WisconsinMedical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.