Phase 4 Vasculitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent before any study-related activities begin.
• People who have been newly diagnosed with, or have experienced a relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), where a doctor has determined that treatment with cyclophosphamide or rituximab is needed.
• People aged 18 or older (or the legal adult age in their country, if that is older than 18).
• People who have tested positive — either now or in the past — for certain antibodies linked to these conditions (called anti-PR3 or anti-MPO antibodies).
• People whose disease is active enough to meet a minimum level of severity based on a standard medical scoring system called the Birmingham Vasculitis Activity Score (BVAS) (confirm with trial site for exact score details).
• People whose kidneys are functioning at or above a certain minimum level, measured by a calculation called eGFR of at least 15 mL/min/1.73 m² (confirm with trial site).

Who may not be able to join:

• People who have bleeding in their lungs (alveolar hemorrhage) that requires invasive breathing machine support expected to continue beyond the study's screening period.
• People who have another autoimmune disease affecting multiple body systems — such as lupus, rheumatoid vasculitis, Sjögren's syndrome, or certain other named conditions — that could affect study results.
• People who have another medical condition that requires ongoing use of immune-suppressing medicines, including steroids, in a way that could affect study results.
• People who have received dialysis or plasma exchange within the 16 weeks before the study start date.
• People who have had a kidney transplant.
• People who have had cancer in the past 5 years (except for certain skin cancers, cervical carcinoma in situ, or breast ductal carcinoma in situ that were fully treated with curative intent).
• People who have an active hepatitis B, hepatitis C, or HIV infection at the time of screening.
• People who have been in known contact with someone who had active tuberculosis (TB) in the 12 weeks before the study start date.
• People who test positive for active or latent (dormant) TB during screening.
• People whose blood test results show certain white blood cell counts below required minimum levels (confirm with trial site for specific values).
• People with significant liver disease, including a prior diagnosis of cirrhosis.
• People whose liver enzyme levels (AST, ALT, or ALP) are more than twice the upper end of the normal range.
• People whose total bilirubin level is more than 1.5 times the upper end of the normal range (people with a documented condition called Gilbert's syndrome may still be eligible if their level is below a slightly higher threshold — confirm with trial site).
• People who have had a serious infection, or an infection requiring intravenous (drip) antibiotic or antifungal treatment, within the 6 weeks before the study start date (note: common mild fungal infections such as thrush do not automatically exclude someone — confirm with trial site).
• People who have had a heart attack, stroke, unstable chest pain, significant heart failure requiring prescription medication, or another significant heart or cardiovascular condition within the 12 weeks before the study start date.
• People who have received cyclophosphamide within 12 weeks before signing consent, with specific exceptions relating to very recent treatment for the current episode of GPA or MPA (confirm with trial site for exact conditions).
• People who have been taking a daily steroid dose of more than 10 mg prednisone (or equivalent) continuously for more than 6 weeks before signing consent.
• People who have received rituximab or other B-cell depleting therapies within 26 weeks before signing consent, with specific exceptions for very recent treatment of the current episode (confirm with trial site for exact conditions).
• People who have received certain immune-modifying medicines — including anti-TNF treatments, abatacept, alemtuzumab, intravenous immunoglobulin, belimumab, or anti-IL-6 medicines such as tocilizumab or sarilumab — within the 16 weeks before the study start date.
• People taking certain medicines that strongly or moderately affect how the body processes drugs (called CYP3A4 inducers), unless those medicines can be safely switched to an alternative at least one week before the study start date.
• People who have taken part in another clinical drug trial within 30 days, or within 5 half-lives of that drug (whichever is longer), before the study start date.
• People who have previously received the study drug avacopan without benefit, or who have received avacopan within 60 days before the study start date.

Important: Always verify eligibility with the trial site directly before applying.