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TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

NCT07176546 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a single center double-blind placebo-controlled study. Patients with GPA and active ears, nose, and throat (ENT) disease in at least two ENT domains, as defined after endoscopic visualization of the upper airway and audiometric evaluation, if applicable, by a single otolaryngologist using a validated GPA ENT disease activity score, will be eligible for inclusion. Patients will be treated with standard of care (SOC) treatment as determined by their treating rheumatologist. In addition to SOC, patients will be randomized to receive TAVNEOS 30mg BID or placebo. Patients will be followed for 52 weeks with standardized ENT assessment along with rheumatologic evaluation of overall disease activity with BVAS.

Conditions

  • Granulomatosis With Polyangiitis
  • Wegener's
  • GPA

Interventions

DRUG

Avacopan

BID dose of 30 mg TAVNEOS (3-10mg capsules)

DRUG

Placebo

BID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules)

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Robert Spiera, MD

    lead OTHER

Principal Investigators

  • Robert F Spiera, MD · Hospital for Special Surgery, New York

  • Lindsay Lally, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-07-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07176546 on ClinicalTrials.gov