TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Conditions

• GPA
• Granulomatosis With Polyangiitis
• Wegener's

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avacopan — DRUG
  BID dose of 30 mg TAVNEOS (3-10mg capsules)
• Placebo — DRUG
  BID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules)

Study Details

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.

Key Dates

First listed

Sep 16, 2025

Start date

May 22, 2026

Status verified

Sep 2026

Primary completion

Jul 31, 2030

Completion

Oct 31, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: TAVNEOS
  BID dose of 30 mg TAVNEOS
• Placebo Comparator: Placebo
  BID dose of 30 mg TAVNEOS-matching placebo

Primary Outcome Measure

Proportion of patients in ENT remission without relapse [ Time Frame: Week 52 ]

Central Contacts

• Liza M Morales, MPH
  212-774-2048
  [email protected]

Locations (2)

Find similar trials in Edison, NJ

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