TAVNEOS for Ear, Nose, and Throat Symptoms of Granulomatosis With Polyangiitis
This study is looking at whether TAVNEOS (avacopan) can help people with Granulomatosis With Polyangiitis (GPA), also known as Wegener's, who have active ear, nose, and throat (ENT) problems. You could be eligible if you have a GPA diagnosis and active ENT disease, confirmed by an ENT doctor. Participants will receive their usual care for GPA, plus either TAVNEOS 30mg twice a day or a placebo (an inactive pill that looks like the study drug). The main goal is to see how many patients achieve ENT remission without their symptoms returning after 52 weeks. The study aims to enroll 30 people.
- Study design
- This is a single-center, double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving TAVNEOS or placebo. Approximately 30 participants will be enrolled.
- What's involved
- You will receive either TAVNEOS 30mg twice daily or a placebo, in addition to your standard care. You will be followed for 52 weeks with regular ENT and rheumatology evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 52 weeks after starting treatment to assess their ENT symptoms and overall disease activity.
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NCT07176546
TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentRobert Spiera, MDInvestigator-initiated
~30 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:AvacopanPlacebo
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients in ENT remission without relapse
Measured over Week 52
Conditions
Where it's being run
2 sites across 2 statesNew Jersey1
New York1
Study leadership
- Robert F Spiera, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
- Lindsay Lally, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 treatment.
Willing and able to provide written informed consent
Adequate liver function as defined by AST or ALT \<2x Upper Limit of Normal
Exclusion
Creatinine \>4.0mg/dl or GFR \<15 at baseline or dependence on dialysis
Respiratory failure requiring mechanical ventilatory support or had experienced alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study
Previous treatment with TAVNEOS within 6 months of screening
Inability to comply with study and/or follow-up procedures at investigator discretion.
Intravenous glucocorticoids in the 4 weeks prior to screening except as premedication prior to infusion of rituximab
Pregnant or breast-feeding
Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg-Strauss), systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein), rheumatoid vasculitis, Sjogren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis
Required dialysis or plasma exchange within 12 weeks prior to screening
Have had a kidney transplant
Any of the following within 12 weeks prior to screening: symptomatic congestive heart failure requiring prescription medication, unstable angina (unless successfully treated with stent or bypass surgery), clinically significant cardiac arrhythmia, myocardial infarction or stroke
History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis
Evidence of tuberculosis based on interferon gamma release assay (IGRA), tuberculin purified protein derivative (PPD) skin test, or chest radiography (X rays or CT scan) done at screening or within 6 weeks prior to screening
HBV, HCV, or HIV viral screening test showing evidence of active or chronic viral infection done at screening or within 6 weeks prior to screening
Received a live vaccine within 4 weeks prior to screening
WBC count less than 3500/uL, or neutrophil count less than 1500/uL, or lymphocyte count less than 500/uL before start of dosing
Evidence of hepatic disease: AST, ALT, alkaline phosphatase, or bilirubin \>3 times the upper limit of normal before start of dosing
Known hypersensitivity to avacopan or inactive ingredients of the TAVNEOS capsules
Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose
Participated previously in an TAVNEOS study
Concurrent use of strong inducers of the CYP450 ie. carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort
Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules (including gelatin, polyethylene glycol, or Cremophor)
History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the patient at unacceptable risk for study participation
What this trial measures
- Proportion of patients in ENT remission without relapseWeek 52
The proportion of patients in ENT remission without relapse in each treatment group at week 52 with no glucocorticoid (GC) exposure 4 weeks prior to week 52, where ENT remission is defined as a score of 0 on GPA ENT disease activity score