Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 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, 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 including eosinophilic granulomatosis
with polyangiitis (Churg-Strauss), systemic lupus erythematosus, immunoglobulin A
vasculitis (Henoch-Schönlein), rheumatoid vasculitis, Sjogren's syndrome,
anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.
- Any 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 12 weeks before signing of the informed
consent.
- Have had a kidney transplant.
- Malignancy except nonmelanoma skin cancers, cervical or breast ductal carcinoma in
situ within the last 5 years before signing the informed consent.
- Acute or chronic, active hepatitis B virus or hepatitis C virus, or human
immunodeficiency virus infection during screening.
- Positive test for active or latent tuberculosis during screening.
- White blood cell count < 3500/µL, neutrophil count < 1500/µL, or lymphocyte count <
500/µl.
- Evidence of clinically significant hepatic disease including prior diagnosis of
cirrhosis.
- aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >2.0
times the upper limit of normal (ULN).
- Total bilirubin > 1.5 times the ULN. A participant with documented Gilbert's syndrome
with total bilirubin < 2 x ULN may be eligible.
- Active infection and/or infection requiring oral or intravenous (IV) antimicrobials
within 4 weeks before signing of the informed consent.
- History of any clinically significant cardiovascular disease, such as symptomatic
congestive heart failure, unstable angina, myocardial infarction or stroke, within 12
weeks before signing of the informed consent.
- Received cyclophosphamide (CYC) within 12 weeks before signing the informed consent;
if on azathioprine, mycophenolate, or methotrexate at the time of screening, these
drugs must be withdrawn before receiving the CYC or rituximab (RTX).
- 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 52 weeks before signing of the
informed consent or within 26 weeks before signing of the informed consent provided
CD19 count > 0.01x10^9/L, or received any of the following within 12 weeks before
signing the informed consent:
- antitumor necrosis factor treatment
- abatacept
- alemtuzumab
- IV immunoglobulin
- belimumab
- tocilizumab.
- 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.
- Received an investigational drug within 30 days or within 5 half-lives (whichever is
longer) before signing of the informed consent.
- Previously received avacopan without clinical benefit per the Investigator's opinion
or received avacopan within 60 days before signing of the informed consent.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.