TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

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.

NCT Number	NCT07176546
Lead Sponsor	Robert Spiera, MD Collaborators: Amgen
Conditions	Granulomatosis With Polyangiitis, Wegener's, GPA
Enrollment	30 participants
Start Date	2026-07
Primary Completion	2030-07 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-06-17