TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
Robert Spiera, MD
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * GPA diagnosis defined by score of ≥5 on 2022 ACR/EULAR Classification Criteria for GPA * Active GPA (both newly diagnosed and relapsing disease) in the ENT domain within 1 month prior to screening, where the active disease is defined as a score of ≥2 on a GPA ENT disease activity score (7 items scored as 1= present 0= absent) performed by direct endoscopic visualization of the upper airway and audiometric evaluation, if applicable, by a single expert otolaryngologist. Items included in the GPA ENT disease activity score are: * Bloody rhinorrhea (Daily blood stained na…
Interventions
- DrugAvacopan
BID dose of 30 mg TAVNEOS (3-10mg capsules)
- DrugPlacebo
BID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules)
Locations (2)
- Hackensack Meridian School of Medicine - Advanced Lung and Airway CenterEdison, New Jersey
- Hospital for Special SurgeryNew York, New York