NCT06072482

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

A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Interventions

Type	Name	Description
DRUG	Avacopan	Administered orally.
DRUG	Placebo	Administered orally.
DRUG	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.

Timeline

• Start date: 2024-02-07
• Primary completion: 2036-12-31
• Completion: 2036-12-31
• First posted: 2023-10-10
• Last updated: 2026-01-29

Locations

68 sites across 5 countries: United States, Czechia, Hungary, Poland, Romania

Regulatory

• FDA-regulated drug study