Phase 1 Vasculitis Trial, Recruiting

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

Who might be able to join this trial:

• You have been diagnosed with a specific type of blood vessel inflammation called ANCA-associated vasculitis — either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), as defined by recognized medical guidelines.
• Your blood tests show a positive result for ANCA antibodies (specifically against PR3 or MPO).
• You are experiencing bleeding in the air sacs of your lungs (a condition called diffuse alveolar hemorrhage).
• Your breathing has become so severely affected that you need a machine to help you breathe (mechanical ventilation).
• Your disease is either newly diagnosed and severe, or a severe return of a previous condition, meeting a specific level of severity as measured by a standard medical scoring tool (confirm with trial site).
• Your disease activity score (called BVAS-WG) is 3 or higher (confirm with trial site).
• You need standard medical treatment to bring your severe ANCA-associated vasculitis under control.

Who may not be able to join:

• You have been diagnosed with a related but different condition called eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss syndrome).
• You have previously had a severe allergic reaction to a medication called avacopan.
• You have a history of a kidney-related condition called anti-GBM disease (also known as Goodpasture's disease).
• You have received the medication avacopan within the last 5 days.
• You are currently taking a medication that strongly affects how your body processes certain drugs (called a strong CYP3A4 inhibitor — confirm with trial site which medications this includes).
• Your recent liver blood tests (taken within the last 3 days) show certain liver values more than 2.5 times above the normal range, unless this is caused by your vasculitis.
• You have evidence of a current or past infection with Hepatitis B, Hepatitis C, or HIV.
• You currently have a serious active infection, including one limited to a specific part of the body.
• You are pregnant or currently breastfeeding.

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