[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gpa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gpa":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644154","ocular-manifestations-of-granulomatosis-with-polyangiitis-100644154",false,"NCT07664709","Ocular Manifestations of Granulomatosis With Polyangiitis.","Inclusion Criteria:\n\nANCA positive vasculitis age 18- no limit patients with onset od the disease and patients already under treatment\n\n\\-\n\nExclusion Criteria:\n\n* no consent for ophthalmic examination\n* inability to udergo ophthalmic examination","ALL","18 Years",{"count":18,"type":19},70,"ESTIMATED","1 Day","OBSERVATIONAL","The current state of knowledge on ANCA-associated vasculitis (AAV) indicates that it is a group of autoimmune diseases in which small blood vessels in various organs are affected. Disease entities included in this group are granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss syndrome).\n\nThese are rare diseases, with an incidence in Europe of approximately 20-25 cases per million people per year. There is a slight predominance among men, and the risk of developing the disease increases with age.\n\nANCA antibodies play a role in the pathogenesis of the disease, and inflammation within small vessels leads to damage of the vessel walls, resulting either in rupture or occlusion of the vessel lumen. Consequently, vital organs such as the kidneys, lungs, heart, nervous system, upper respiratory tract, gastrointestinal tract, and eyes may be affected.\n\nIf the disease is not diagnosed, untreated, or treated improperly, it can lead to irreversible failure of these organs and even death. Despite appropriate treatment, AAV diseases tend to relapse; therefore, therapy consists of two phases: induction therapy and maintenance therapy.\n\nCurrent EULAR\u002FEDTA guidelines for induction treatment of AAV recommend the use of cyclophosphamide (CYC) or rituximab (RTX) in combination with glucocorticosteroids in cases of severe disease. If remission is achieved after induction therapy, maintenance treatment should be initiated with drugs such as azathioprine, mycophenolate mofetil, methotrexate, or rituximab, combined with a low dose of glucocorticosteroids. Maintenance therapy should last no less than two years.\n\nThe study will focus on ophthalmological evaluation of patients diagnosed with ANCA-associated vasculitis. In this disease, all structures of the eye may be involved. The most common ocular manifestations include scleritis, keratitis, proptosis, inflammation of orbital tissues, nasolacrimal duct obstruction, and orbital involvement leading to proptosis, double vision, and restricted eye movement.\n\nUntil recently, the disease was often fatal. However, advances in diagnostics and current pharmacological treatment options, combined with appropriately aggressive immunosuppressive therapy, have significantly improved survival, enhanced patients' quality of life, and reduced mortality. Early diagnosis and prompt initiation of appropriate therapy are crucial.",[24,25,26,27],"GPA","Vasculitis","Microscopic Polyangiitis (MPA)","Churg-Strauss Syndrome (CSS)",[29,30,31,32,33],"ocular symptoms","octa","ocular manifestations","scleritis GPA","gpa ocular involvement","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2024-03-01",{"date":42,"type":19},"2026-12-31",{"name":44,"class":45},"Military Institute od Medicine National Research Institute","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100606514","phase-2-tavneos-for-otolaryngologic-manifestations-of-granulomatosis-with-polyangiitis-100606514","NCT07176546","TAVNEOS for Otolaryngologic Manifestations of Granulomatosis With Polyangiitis","Inclusion Criteria:\n\n* GPA diagnosis defined by score of ≥5 on 2022 ACR\u002FEULAR Classification Criteria for GPA\n* 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:\n\n  * Bloody rhinorrhea (Daily blood stained nasal discharge)\n  * Objective stridor (Stridor assessed by doctor)\n  * Inflammation on nasal examination (Ulcers, granulation, friable mucosa on rigid nasal endoscopy. Excluding crusting)\n  * Inflammation on flexible laryngoscopy (Ulcers, granulation, friable mucosa in the larynx)\n  * Inflamed TM\\*\u002Fmiddle ear (Persistent inflammation or granulation tissue in tympanic membrane\u002Fmiddle ear)\n  * Sudden sensorineural hearing loss (30db drop in 3 frequencies within 72 hours)\n* Other ENT\u002Fupper airway manifestations of active GPA observed during structured ENT exam including but not limited to lacrimal gland dacryocystitis and endobronchial disease\n* Age 18 and older\n* Willing and able to comply with treatment and follow-up procedures\n* 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.\n* Willing and able to provide written informed consent\n* Adequate liver function as defined by AST or ALT \\\u003C2x Upper Limit of Normal\n\nExclusion Criteria:\n\n* Creatinine \\>4.0mg\u002Fdl or GFR \\\u003C15 at baseline or dependence on dialysis\n* 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\n* Previous treatment with TAVNEOS within 6 months of screening\n* Inability to comply with study and\u002For follow-up procedures at investigator discretion.\n* Intravenous glucocorticoids in the 4 weeks prior to screening except as premedication prior to infusion of rituximab\n* Pregnant or breast-feeding\n* 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\n* Required dialysis or plasma exchange within 12 weeks prior to screening\n* Have had a kidney transplant\n* 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\n* 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\n* 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\n* 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\n* Received a live vaccine within 4 weeks prior to screening\n* WBC count less than 3500\u002FuL, or neutrophil count less than 1500\u002FuL, or lymphocyte count less than 500\u002FuL before start of dosing\n* Evidence of hepatic disease: AST, ALT, alkaline phosphatase, or bilirubin \\>3 times the upper limit of normal before start of dosing\n* Known hypersensitivity to avacopan or inactive ingredients of the TAVNEOS capsules\n* 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\n* Participated previously in an TAVNEOS study\n* Concurrent use of strong inducers of the CYP450 ie. carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort\n* Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules (including gelatin, polyethylene glycol, or Cremophor)\n* 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",{"count":54,"type":19},30,"INTERVENTIONAL",[57,58],"PHASE2","PHASE3","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.",[61,62,24],"Granulomatosis With Polyangiitis","Wegener's",[64,65,24,66],"Tavneos","avacopan","ENT","NOT_YET_RECRUITING","2026-06-16",{"date":35,"type":38},{"date":71,"type":19},"2026-07",{"date":73,"type":19},"2030-10",{"name":75,"class":45},"Robert Spiera, MD"]