TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Part of paid clinical trials in Edison, New Jersey.

Sponsor
Robert Spiera, MD
Study ID
NCT07176546
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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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

Start date
Jul 31, 2026
Status verified
Sep 2025
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

Locations (2)

FacilityCityStateZIPSite coordinators
Hackensack Meridian School of Medicine - Advanced Lung and Airway CenterEdisonNew Jersey08820
Russell S Martins, MD
[email protected]
732-298-2638
Robert Lebovics, MD (SUB_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Liza M Morales, MPH
[email protected]
212-774-2048
Robert F Spiera, MD (PRINCIPAL_INVESTIGATOR)
Lindsay Lally, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Hackensack Meridian School of Medicine - Advanced Lung and Airway Center· Edison, NJHospital for Special Surgery· New York, NY

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