Recruiting
Phase 2
Phase 3

TAVNEOS

Sponsor:

Robert Spiera, MD

Code:

NCT07176546

Conditions

Granulomatosis With Polyangiitis

Wegener's

GPA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Avacopan

Placebo

Study Details

Brief 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.

Conditions

Granulomatosis With Polyangiitis

Wegener's

GPA

Study ID

NCT07176546

Start date

May 22, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2030

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 treatment.
  • Willing and able to provide written informed consent
  • Adequate liver function as defined by AST or ALT <2x Upper Limit of Normal

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TAVNEOS

BID dose of 30 mg TAVNEOS

placebo comparator: Placebo

BID dose of 30 mg TAVNEOS-matching placebo

Interventions

Avacopan

BID dose of 30 mg TAVNEOS (3-10mg capsules)

Placebo

BID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Liza M Morales, MPH

212-774-2048moralesli@hss.edu

Locations

Hackensack Meridian School of Medicine - Advanced Lung and Airway Center

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Robert Lebovics, MD

732-321-7000robert.lebovics@hmhn.org

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Liza M Morales, MPH

212-774-2048moralesli@hss.edu

Principal Investigator:

Robert F Spiera, MD

More Information

Sponsor

Robert Spiera, MD

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Keywords

  • Tavneos
  • avacopan
  • GPA
  • ENT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Spiera, MD on 2026-09-02.