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

NCT06072482 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2036-12-31
Completion
2036-12-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Hungary
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072482 on ClinicalTrials.gov