Granulomatosis With PolyangiitisPhase 2/3NCT07176546
TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
A Phase 2/3 study testing Avacopan in people with Granulomatosis With Polyangiitis and Wegener's, run by Robert Spiera, MD at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis, Wegener's, GPA
- What is being tested?
- Avacopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2026to Oct 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hackensack Meridian School of Medicine - Advanced Lung and Airway Center
Edison, New Jersey, 08820
Robert Lebovics, MD, 732-321-7000, robert.lebovics@hmhn.org
Robert Lebovics, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Liza M Morales, MPH, 212-774-2048, moralesli@hss.edu
Robert F Spiera, MD
About this study
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
- Being tested
- Avacopan, Placebo
- Keywords
- Tavneos, avacopan, GPA, ENT
- Medical subject headings
- Granulomatosis with Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvacopanDrug
Also called TAVNEOS
BID dose of 30 mg TAVNEOS (3-10mg capsules)
PlaceboDrug
BID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules)
| Study group | Role | What they receive |
|---|---|---|
| TAVNEOS | Active comparator | BID dose of 30 mg TAVNEOS Receives: Drug: Avacopan |
| Placebo | Placebo comparator | BID dose of 30 mg TAVNEOS-matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in ENT remission without relapse
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
Measured: Week 52
Secondary outcomes (12)
Mean ENT disease activity score
Comparison of mean ENT disease activity scores between treatment groups at week 52
Measured: Week 52
Change in ENT disease activity score
Change in ENT GPA disease activity score between week 26 and week 52
Measured: Between week 26 and week 52
Proportion of patients in ENT remission with BVAS 0 at week 52 and sustained remission
Proportion of patients in remission with BVAS 0 at week 52 and sustained remission from week 26 to week 52 with BVAS 0 and no glucocorticoids for 4 weeks prior to assessment
Measured: Week 52
Cumulative steroid dose
Measured: Through study completion, an average of 60 weeks
Duration of steroid-free remission
Measured: Through study completion, an average of 60 weeks
Change in Vasculitis Damage Index (VDI)
Change in VDI in the ENT domain at week 52
Measured: Week 52
Sino-nasal Outcome Test (SNOT-22)
Scale 0-110 (Higher score equals worse outcome)
Measured: Through study completion, an average of 60 weeks
ANCA-Associated Vasculitis Patient-Reported Outcome (AAV-PRO)
Scale 0-119 (Higher score equals worse outcome)
Measured: Through study completion, an average of 60 weeks
Number of surgical procedures in the ENT domain required
Number of surgical procedures in the ENT domain required during the study period
Measured: Through study completion, an average of 60 weeks
Number of ENT flares
Number of ENT flares as measured by the rise in GPA ENT DAS (defined by an increase of ≥1 point on the GPA ENT DAS)
Measured: Through study completion, an average of 60 weeks
Time to ENT relapse
Measured: Through study completion, an average of 60 weeks
Number of GPA flares
Number of GPA flares as measured by Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS-WG)
Measured: Through study completion, an average of 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start22 May 2026
- Primary completionJul 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Spiera, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Robert Spiera, MD, Hospital for Special Surgery, New York
- Investigators
- Robert F Spiera, MD, Principal investigator, Hospital for Special Surgery, New YorkLindsay Lally, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176546
- Sponsor's protocol ID
- 2023-1580
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
- ClinicalTrials.gov ID
- NCT07176546
- Acronym / sponsor ID
- 2023-1580
- Conditions
- Granulomatosis With Polyangiitis, Wegener's, GPA
- Keywords
- Tavneos, avacopan, GPA, ENT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Robert Spiera, MDUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 22 May 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVNEOS | Active comparator | Drug: AvacopanBID dose of 30 mg TAVNEOS |
| Placebo | Placebo comparator | Drug: PlaceboBID dose of 30 mg TAVNEOS-matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvacopanAlso: TAVNEOSBID dose of 30 mg TAVNEOS (3-10mg capsules) | Drug | TAVNEOS |
| PlaceboBID dose of 30mg TAVNEOS-matching placebo (3-10mg capsules) | Drug | Placebo |
Primary outcome
Proportion of patients in ENT remission without relapse
Time frame: Week 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
12 secondary outcomes
Mean ENT disease activity score
Time frame: Week 52
Change in ENT disease activity score
Time frame: Between week 26 and week 52
Proportion of patients in ENT remission with BVAS 0 at week 52 and sustained remission
Time frame: Week 52
Cumulative steroid dose
Time frame: Through study completion, an average of 60 weeks
Duration of steroid-free remission
Time frame: Through study completion, an average of 60 weeks
Change in Vasculitis Damage Index (VDI)
Time frame: Week 52
Sino-nasal Outcome Test (SNOT-22)
Time frame: Through study completion, an average of 60 weeks
ANCA-Associated Vasculitis Patient-Reported Outcome (AAV-PRO)
Time frame: Through study completion, an average of 60 weeks
Number of surgical procedures in the ENT domain required
Time frame: Through study completion, an average of 60 weeks
Number of ENT flares
Time frame: Through study completion, an average of 60 weeks
Time to ENT relapse
Time frame: Through study completion, an average of 60 weeks
Number of GPA flares
Time frame: Through study completion, an average of 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert F Spiera, MD principal investigator
Hospital for Special Surgery, New York
Lindsay Lally, MD principal investigator
Hospital for Special Surgery, New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Avacopan in people with Granulomatosis With Polyangiitis and Wegener's, run by Robert Spiera, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liza M Morales, MPH (212-774-2048, moralesli@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in ENT remission without relapse (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.