TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis (NCT07176546) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
United States30 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 nasal discharge)
* Objective stridor (Stridor assessed by doctor)
* Inflammation on nasal examination (Ulcers, granulation, friable mucosa on rigid nasal endoscopy. Excluding crusting)
* Inflammation on flexible laryngoscopy (Ulcers, granulation, friable mucosa in the larynx)
* Inflamed TM\*/middle ear (Persistent inflammation or granulation tissue in tympanic membrane/middle ear)
* Sudden sensorineural hearing loss (30db drop in 3 frequencies within 72 hours)
* Other ENT/upper airway manifestations of active GPA observed during structured ENT exam including but not limited to lacrimal gland dacryocystitis and endobronchial disease
* Age 18 and older
* Willing and able to comply with treatment and follow-up procedures
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatme…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused specifically on ear, nose, and throat symptoms of GPA — things like sinus disease, hearing loss, or nasal crusting — would my particular ENT manifestations make me a reasonable candidate to discuss with my care team?
2This is a Phase 2/3 trial testing TAVNEOS (avacopan) for GPA, and it hasn't started recruiting yet — given that timeline uncertainty, should I be considering standard-of-care treatments like rituximab or cyclophosphamide now rather than waiting to see if I might enroll?
3The trial is measuring 'ENT remission without relapse' as its main goal — can you help me understand what remission of ENT symptoms actually looks like in GPA, and how that outcome would be tracked over time if I were ever to participate?
4TAVNEOS has already been approved for ANCA-associated vasculitis more broadly, so what do we already know about its safety profile, and what new risks or unknowns might this trial be exploring specifically for ENT disease?
5Since the trial isn't recruiting yet, is there anything I should be doing now — like documenting my current ENT symptoms or getting specific tests — so that my care team has the information needed to evaluate whether this study might be worth revisiting when it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients in ENT remission without relapse