Recruiting
Phase 1

Avacopan

Sponsor:

Mayo Clinic

Code:

NCT07556484

Conditions

Diffuse Alveolar Hemorrhage

Antineutrophil Cytoplasmic Antibody Positive Vasculitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Avacopan

Study Details

Brief summary:

The purpose of this study is to determine the 72-hour pharmacokinetics of emulsified avacopan at a dose of 30 mg twice daily given to up to 6 patients with active severe GPA or MPA with diffuse alveolar hemorrhage (DAH) requiring mechanical ventilation for respiratory support.

Conditions

Diffuse Alveolar Hemorrhage

Antineutrophil Cytoplasmic Antibody Positive Vasculitis

Study ID

NCT07556484

Start date

Aug 1, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis MPA).
  • Positivity for ANCA, directed against PR3 or MPO.
  • Diffuse alveolar hemorrhage.
  • Respiratory failure requiring mechanical ventilation.
  • Severe newly diagnosed disease or severe relapsing disease. Severe new or relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.
  • Minimum BVAS-WG of 3.
  • Requirement of standard-of-care remission induction therapy for active severe ANCA-associated vasculitis (GPA or MPA).

Exclusion Criteria

  • Diagnosis with eosinophilic granulomatosis with polyangiitis (EGPA, formally Churg-Strauss syndrome) as defined by the Chapel Hill consensus conference.
  • Allergies: History of severe allergic reaction to avacopan
  • History of documented anti-glomerular basement membrane disease (anti-GBM disease)
  • Previous administration of avacopan within the last 5 days.
  • Concomitant use of a strong CYP3A4 inhibitor.
  • Aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\], alkaline phosphatase, or total bilirubin elevation >2.5 times the upper limit of normal (unless attributed to vasculitis) on routine liver function testing obtained within 3 days prior to anticipated treatment with avacopan.
  • Evidence of prior active or current Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency (HIV) infection.
  • Active serious infection, including localized infection.
  • Pregnancy and breastfeeding

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Avacopan

Subjects will receive solubilized avacopan at a dose of 30 mg twice daily for 3 consecutive days, applied via NG tube.

Interventions

Avacopan

Avacopan capsules will be solubilized in heated water and administered to patients with Diffuse Alveolar Hemorrhage (DAH) due to GPA or MPA via nasogatric tube.

Primary outcome measure

  • Change in Avacopan blood level over time [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Josie Baum

507-422-9010baum.josephine@mayo.edu

Michael Stachowitz

stachowitz.michael@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Josie Baum

507-422-9010baum.josephine@mayo.edu

Principal Investigator:

Ulrich Specks, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-06.