[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06321601":3,"trial-entities:NCT06321601":368,"trial-summary:NCT06321601":375},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":45,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":15,"eligibility_criteria":83,"std_ages":102,"locations":104,"central_contacts":358,"overall_officials":359,"references":363,"see_also_links":364},"NCT06321601","20230070","Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to \u003C 18 Years of Age With AAV.","A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to \u003C 18 Years of Age With Active ANCA-associated Vasculitis (AAV)","ACTIVE_NOT_RECRUITING","2027-07-18","2026-07","2026-07-20","2024-10-22","Amgen","INDUSTRY",false,"The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.",null,[19],"Vasculitis",[21,22,23],"Pediatric","Avacopan","Tavneos®","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},19,"ACTUAL",[32],{"type":33,"name":22,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Oral administration",[22],[37],"AMG 569",[39,42],{"measure":40,"timeFrame":41},"Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS)","Week 26",{"measure":43,"timeFrame":44},"Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS","Week 52",[46,49,53,55,57,60,62,65,67,69,71,74,78],{"measure":47,"timeFrame":48},"Plasma Concentrations of Avacopan","Day 1 up to Week 52",{"measure":50,"description":51,"timeFrame":52},"Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)","TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability\u002Fincapacity, a congenital anomaly\u002Fbirth defect, or another medically important serious event.","Day 1 up to approximately Week 60",{"measure":54,"timeFrame":41},"Proportion of Participants Achieving Disease Remission at Week 26 According to the Birmingham Vasculitis Activity Score (BVAS)",{"measure":56,"timeFrame":44},"Proportion of Participants Achieving Disease Remission at Week 52 According to the BVAS",{"measure":58,"timeFrame":59},"Proportion of Participants With PVAS of 0 Over Time Through Week 52","Up to Week 52",{"measure":61,"timeFrame":59},"Proportion of Participants With BVAS of 0 Over Time Through Week 52",{"measure":63,"timeFrame":64},"Change From Baseline Over 52 Weeks in Urinary Albumin-Creatinine Ratio (UACR)","Baseline up to Week 52",{"measure":66,"timeFrame":64},"Change From Baseline Over 52 Weeks in Estimated Glomerular Filtration Rate (eGFR)",{"measure":68,"timeFrame":64},"Change From Baseline Over 52 Weeks In Physician Global Assessment (PGA) of Disease Activity",{"measure":70,"timeFrame":64},"Change From Baseline Over 52 Weeks in Pediatric Vasculitis Damage Index (PVDI)",{"measure":72,"timeFrame":73},"Number of Glucocorticoid Dosages Administered","Screening up to Week 52",{"measure":75,"description":76,"timeFrame":77},"Proportion of Participants Across the Taste Score Categories of the TASTY Faces Scale","The TASTY faces scale will be utilized to assess the taste of the oral pediatric formulation. A 7-point version of the scale will be used, where higher scores correspond to faces showing favorable tastes. Upon drug administration, the child will be shown the TASTY scale and asked to rate his\u002Fher perception of tastiness by pointing to the appropriate face on the scale.","Day 1 and Week 2",{"measure":79,"description":76,"timeFrame":77},"Taste and Acceptability Score of Avacopan per TASTY Faces Scale","ALL","6 Years","17 Years",{"inclusion":84,"exclusion":91,"raw_text":101},[85,86,87,88,89,90],"Male and female children and adolescents from 6 to \\\u003C 18 years old of age.","Clinical diagnosis of Granulomatosis with Polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013).","Positive anti-PR3(Anti-Proteinase 3) or anti-MPO(Anti-Myeloperoxidase) antibody documented at Screening or historically. Historical positivity is acceptable (even if Screening is negative) if supported by verifiable lab source documentation obtained during AAV diagnosis or disease course; use the most recent positive result.","At least 1 PVAS major item, at least 3 PVAS nonmajor items, or atleast the 2 renal items of proteinuria and hematuria.","Estimated glomerular filtration rate (eGFR) of ≥ 15 mL\u002Fminute\u002F1.73 m\\^2 at screening and day 1.","Participants must have a bodyweight of ≥ 15 kg at day 1.",[92,93,94,95,96,97,98,99,100],"Any other known multisystem autoimmune disease including and not limited to eosinophilic granulomatosis with polyangiitis (EGPA, previously, Churg-Strauss disease), systemic lupus erythematosus, IgA vasculitis \u002F Henoch-Schönlein, Purpura, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.","Renal replacement therapy \u002F plasmapheresis: subjects will be excluded who received, require, or initiate CRRT (continuous renal replacement therapy), hemodialysis, any renal dialysis, or plasmapheresis within 14 days prior to Screening or between Screening and Day 1.","History of kidney transplantation or is anticipated to require renal transplantation during the study.","Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.","Any medical condition requiring, or expected to require, ongoing treatment with immunosuppressive, therapy (including systemic glucocorticoids) for a non-AAV indication that in the judgment of the investigator, could confound study assessments or interpretation of study results.","Female subjects of childbearing potential must have a negative highly sensitive serum pregnancy test at Screening and a negative sensitive urine pregnancy test, on day 1, with results confirmed prior to the first administration of investigational product.","Known hypersensitivity or contraindication to avacopan, its excipients, or to any investigational product or required concomitant medication used in this study.","Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.","History or evidence of any other clinically significant disorder, condition, or disease (other than those specified above) that, in the investigator's judgment, would pose an unacceptable risk to subject safety, or interfere with study assessments or completion. The investigator may consult the Amgen medical monitor as needed. The rationale for exclusion and any consultation must be documented in the subject's source record.","Inclusion Criteria:\n\n* Male and female children and adolescents from 6 to \\\u003C 18 years old of age.\n* Clinical diagnosis of Granulomatosis with Polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013).\n* Positive anti-PR3(Anti-Proteinase 3) or anti-MPO(Anti-Myeloperoxidase) antibody documented at Screening or historically. Historical positivity is acceptable (even if Screening is negative) if supported by verifiable lab source documentation obtained during AAV diagnosis or disease course; use the most recent positive result.\n* At least 1 PVAS major item, at least 3 PVAS nonmajor items, or atleast the 2 renal items of proteinuria and hematuria.\n* Estimated glomerular filtration rate (eGFR) of ≥ 15 mL\u002Fminute\u002F1.73 m\\^2 at screening and day 1.\n* Participants must have a bodyweight of ≥ 15 kg at day 1.\n\nExclusion Criteria:\n\n* Any other known multisystem autoimmune disease including and not limited to eosinophilic granulomatosis with polyangiitis (EGPA, previously, Churg-Strauss disease), systemic lupus erythematosus, IgA vasculitis \u002F Henoch-Schönlein, Purpura, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.\n* Renal replacement therapy \u002F plasmapheresis: subjects will be excluded who received, require, or initiate CRRT (continuous renal replacement therapy), hemodialysis, any renal dialysis, or plasmapheresis within 14 days prior to Screening or between Screening and Day 1.\n* History of kidney transplantation or is anticipated to require renal transplantation during the study.\n* Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.\n* Any medical condition requiring, or expected to require, ongoing treatment with immunosuppressive, therapy (including systemic glucocorticoids) for a non-AAV indication that in the judgment of the investigator, could confound study assessments or interpretation of study results.\n* Female subjects of childbearing potential must have a negative highly sensitive serum pregnancy test at Screening and a negative sensitive urine pregnancy test, on day 1, with results confirmed prior to the first administration of investigational product.\n* Known hypersensitivity or contraindication to avacopan, its excipients, or to any investigational product or required concomitant medication used in this study.\n* Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease (other than those specified above) that, in the investigator's judgment, would pose an unacceptable risk to subject safety, or interfere with study assessments or completion. The investigator may consult the Amgen medical monitor as needed. The rationale for exclusion and any consultation must be documented in the subject's source record.",[103],"CHILD",[105,114,122,130,138,146,153,161,168,176,184,192,199,208,215,223,231,239,243,251,258,265,268,276,283,291,298,305,313,322,329,336,344,351],{"facility":106,"city":107,"state":108,"zip":109,"country":110,"geoPoint":111},"Emory University","Atlanta","Georgia","30322","United States",{"lat":112,"lon":113},33.749,-84.38798,{"facility":115,"city":116,"state":117,"zip":118,"country":110,"geoPoint":119},"Riley Hospital for Children","Indianapolis","Indiana","46202",{"lat":120,"lon":121},39.76838,-86.15804,{"facility":123,"city":124,"state":125,"zip":126,"country":110,"geoPoint":127},"University of Minnesota Masonic Childrens Hospital Discovery Clinic","Minneapolis","Minnesota","55454",{"lat":128,"lon":129},44.97997,-93.26384,{"facility":131,"city":132,"state":133,"zip":134,"country":110,"geoPoint":135},"Cohen Children Medical Center","Lake Success","New York","11042",{"lat":136,"lon":137},40.77066,-73.71763,{"facility":139,"city":140,"state":141,"zip":142,"country":110,"geoPoint":143},"University of North Carolina","Chapel Hill","North Carolina","27599",{"lat":144,"lon":145},35.9132,-79.05584,{"facility":147,"city":148,"state":141,"zip":149,"country":110,"geoPoint":150},"Wake Forest University Health Sciences","Charlotte","28203",{"lat":151,"lon":152},35.22709,-80.84313,{"facility":154,"city":155,"state":156,"zip":157,"country":110,"geoPoint":158},"Akron Childrens Hospital","Akron","Ohio","44308",{"lat":159,"lon":160},41.08144,-81.51901,{"facility":162,"city":163,"state":156,"zip":164,"country":110,"geoPoint":165},"Cleveland Clinic Foundation","Cleveland","44195",{"lat":166,"lon":167},41.4995,-81.69541,{"facility":169,"city":170,"state":171,"zip":172,"country":110,"geoPoint":173},"University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224",{"lat":174,"lon":175},40.44062,-79.99589,{"facility":177,"city":178,"state":179,"zip":180,"country":110,"geoPoint":181},"Texas Childrens Hospital","Houston","Texas","77030",{"lat":182,"lon":183},29.76328,-95.36327,{"facility":185,"city":186,"zip":187,"country":188,"geoPoint":189},"Universitair Ziekenhuis Gent","Ghent","9000","Belgium",{"lat":190,"lon":191},51.05,3.71667,{"facility":193,"city":194,"zip":195,"country":188,"geoPoint":196},"Universitair Ziekenhuis Leuven - Gasthuisberg","Leuven","3000",{"lat":197,"lon":198},50.87959,4.70093,{"facility":200,"city":201,"state":202,"zip":203,"country":204,"geoPoint":205},"Alberta Childrens Hospital","Calgary","Alberta","T3B 6A8","Canada",{"lat":206,"lon":207},51.05011,-114.08529,{"facility":209,"city":210,"state":202,"zip":211,"country":204,"geoPoint":212},"Stollery Childrens Hospital","Edmonton","T6G 1C9",{"lat":213,"lon":214},53.55014,-113.46871,{"facility":216,"city":217,"state":218,"zip":219,"country":204,"geoPoint":220},"British Columbia Childrens Hospital","Vancouver","British Columbia","V6H 3N1",{"lat":221,"lon":222},49.24966,-123.11934,{"facility":224,"city":225,"state":226,"zip":227,"country":204,"geoPoint":228},"CHU Sainte Justine","Montreal","Quebec","H3T 1C5",{"lat":229,"lon":230},45.50884,-73.58781,{"facility":232,"city":233,"zip":234,"country":235,"geoPoint":236},"Vseobecna fakultni nemocnice v Praze","Prague","128 08","Czechia",{"lat":237,"lon":238},50.08804,14.42076,{"facility":240,"city":233,"zip":241,"country":235,"geoPoint":242},"Fakultni nemocnice Motol a Homolka","150 06",{"lat":237,"lon":238},{"facility":244,"city":245,"zip":246,"country":247,"geoPoint":248},"Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin","Bordeaux","33076","France",{"lat":249,"lon":250},44.84124,-0.58046,{"facility":252,"city":253,"zip":254,"country":247,"geoPoint":255},"Hospices Civils de Lyon Hopital Femme Mere Enfant","Bron","69677",{"lat":256,"lon":257},45.73865,4.91303,{"facility":259,"city":260,"zip":261,"country":247,"geoPoint":262},"Hopital Necker Enfants Malades","Paris","75015",{"lat":263,"lon":264},48.85341,2.3488,{"facility":266,"city":260,"zip":261,"country":247,"geoPoint":267},"Hopital Necker",{"lat":263,"lon":264},{"facility":269,"city":270,"zip":271,"country":272,"geoPoint":273},"Semmelweis Egyetem","Budapest","1094","Hungary",{"lat":274,"lon":275},47.49835,19.04045,{"facility":277,"city":278,"zip":279,"country":272,"geoPoint":280},"Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar","Szeged","6720",{"lat":281,"lon":282},46.253,20.14824,{"facility":284,"city":285,"zip":286,"country":287,"geoPoint":288},"Uniwersyteckie Centrum Kliniczne","Gdansk","80-952","Poland",{"lat":289,"lon":290},54.35227,18.64912,{"facility":292,"city":293,"zip":294,"country":287,"geoPoint":295},"Uniwersytecki Szpital Dzieciecy w Krakowie","Krakow","30-663",{"lat":296,"lon":297},50.06143,19.93658,{"facility":299,"city":300,"zip":301,"country":287,"geoPoint":302},"Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie","Warsaw","02-091",{"lat":303,"lon":304},52.22977,21.01178,{"facility":306,"city":307,"zip":308,"country":309,"geoPoint":310},"Narodny ustav detskych chorob","Bratislava","833 40","Slovakia",{"lat":311,"lon":312},48.14816,17.10674,{"facility":314,"city":315,"state":316,"zip":317,"country":318,"geoPoint":319},"Hospital Universitari Vall d Hebron","Barcelona","Catalonia","08035","Spain",{"lat":320,"lon":321},41.38879,2.15899,{"facility":323,"city":324,"state":316,"zip":325,"country":318,"geoPoint":326},"Hospital Sant Joan de Deu","Esplugues de Llobregat","08950",{"lat":327,"lon":328},41.37732,2.08809,{"facility":330,"city":331,"zip":332,"country":318,"geoPoint":333},"Hospital Universitario 12 de Octubre","Madrid","28041",{"lat":334,"lon":335},40.4165,-3.70256,{"facility":337,"city":338,"zip":339,"country":340,"geoPoint":341},"Hacettepe Universitesi Tip Fakultesi Hastanesi","Ankara","06100","Turkey (Türkiye)",{"lat":342,"lon":343},39.91987,32.85427,{"facility":345,"city":346,"zip":347,"country":340,"geoPoint":348},"Umraniye Egitim ve Arastirma Hastanesi","Istanbul","34764",{"lat":349,"lon":350},41.01384,28.94966,{"facility":352,"city":353,"zip":354,"country":340,"geoPoint":355},"Erciyes Universitesi Tip Fakultesi Hastanesi","Kayseri","38030",{"lat":356,"lon":357},38.73222,35.48528,[],[360],{"name":361,"affiliation":13,"role":362},"MD","STUDY_DIRECTOR",[],[365],{"label":366,"url":367},"AmgenTrials clinical trials website","http:\u002F\u002Fwww.amgentrials.com",{"nct_id":4,"conditions":369,"biomarkers":372},[370,371],"Granulomatosis with Polyangiitis","Microscopic Polyarteritis",[373,374],"Antimyeloperoxidase antibody","Myeloblastin",{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]