NCT07176546

TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Robert Spiera, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Avacopan	BID dose of 30 mg TAVNEOS (3-10mg capsules)
DRUG	Placebo	BID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules)

Timeline

• Start date: 2026-07-01
• Primary completion: 2030-07-01
• Completion: 2030-10-01
• First posted: 2025-09-16
• Last updated: 2025-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study