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Recruiting Phase 4

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

NCT06072482 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 4
Started
2024-02-07
Last updated
2026-09-30

Condition(s) studied

Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Investigational drug(s) / intervention(s)

Avacopan →PlaceboStandard of Care

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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. 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). 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 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.

Primary outcome measure(s)

  • Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) — Up to Month 60
  • Percentage of Participants Experiencing Adverse Events of Special Interest — Up to Month 60
  • Percentage of Participants Experiencing Serious Adverse Events — Up to Month 60
  • Percentage of Participants Experiencing Adverse Events Leading to Withdrawal — Up to Month 60
  • Percentage of Participants Experiencing Adverse Events Leading to Death — Up to Month 60
  • Number of Participants Experiencing Clinical Significant Changes from Baseline in Vital Signs Measurements — Up to Month 60
  • Number of Participants Experiencing Clinical Significant Changes from Baseline in Hematology Assessments — Up to Month 60
  • Number of Participants Experiencing Clinical Significant Changes from Baseline in Serum Chemistry Assessments — Up to Month 60
  • Number of Participants Experiencing Clinical Significant Changes from Baseline in Urinalysis Assessments — Up to Month 60

Trial sites (83)

FacilityCityRegionStatus
Orthopedic Physicians Alaska Anchorage Alaska Terminated
Scottsdale Healthcare at Shea - HonorHealth Scottsdale Arizona Recruiting
Southwest Kidney Institute Surprise Arizona Recruiting
Unity Health Searcy Arkansas Recruiting
Medvin Clinical Research Covina California Terminated
Palo Alto Medical Foundation Fremont Fremont California Recruiting
The Nephrology Group Fresno California Recruiting
Providence Medical Foundation Fullerton California Recruiting
Southland Arthritis and Osteoarthritis Medical Center, Inc Menifee California Recruiting
University of California San Francisco- Zuckerburg San Francisco General San Francisco California Recruiting
Harbor University of California at Los Angeles Medical Center Torrance California Recruiting
Amicis Research Center Valencia California Recruiting
University of Colorado Aurora Colorado Recruiting
Florida Kidney Physicians Boca Raton Florida Recruiting
Malcom Randall Veterans Affairs Medical Center Gainesville Florida Recruiting
Mayo Clinic Jacksonville Florida Recruiting
ClinTrial Research Oakwater, Llc Orlando Florida Recruiting
University of South Florida Tampa Florida Recruiting
Emory University Atlanta Georgia Recruiting
Lake Cumberland Rheumatology New Albany Indiana Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Dunes Clinical Research LLC Sioux City Iowa Recruiting
University of Kentucky Lexington Kentucky Recruiting
Johns Hopkins Bayview Medical Center Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Brigham and Womens Hospital Boston Massachusetts Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Kidney Michigan Institute Saginaw Michigan Recruiting
Clinical Research Institute of Michigan Saint Clair Shores Michigan Recruiting
Revive Research Institute Sterling Heights Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Renown Rheumatology Reno Nevada Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
Renal Medicine Associates Albuquerque New Mexico Recruiting
New York Nephrology Vasculitis and Glomerular Center Albany New York Recruiting
Northwell Health Great Neck New York Recruiting
Hospital For Special Surgery New York New York Recruiting
Carolina Kidney Associates Greensboro North Carolina Recruiting
East Carolina University Brody Outpatient Center Greenville North Carolina Recruiting

+ 43 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06072482 on ClinicalTrials.gov ↗ ← All trials in the USA