MedTrace Logo

Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

NCT06611696 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are:

Is avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan?

Participants will:

Be treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks).

Be assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission/relapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events.

The primary endpoint is remission rates at 26 weeks.

Conditions

  • ANCA Associated Vasculitis (AAV)

Interventions

DRUG

Avacopan, prednisolone and rituximab

Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.

DRUG

Prednisolone and rituximab

Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • International University of Health and Welfare

    collaborator OTHER

  • Chiba University

    lead OTHER

Principal Investigators

  • Masayoshi Harigai, MD, PhD · International University of Health and Welfare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2027-03-31
Completion
2028-09-30

Countries

  • Japan

Study Locations

More Related Trials

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 NCT06611696 on ClinicalTrials.gov