[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605109":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":156,"collaborators":38,"id":158,"slug":38,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":38,"studyType":171,"phases":172,"briefSummary":174,"conditions":175,"keywords":38,"overallStatus":45,"whyStopped":38,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Afimkibart Dose A","EXPERIMENTAL","Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.",[13],"Drug: Afimkibart",{"label":15,"type":10,"description":16,"interventionNames":17},"Afimkibart Dose B","Participants will receive Afimkibart IV followed by Afimkibart SC.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Afimkibart","Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.",[9,15],[25,26,27,28],"PF-06480605","RVT-3101","RG6631","RO7790121",[30],{"name":31,"affiliation":5,"role":32},"Clinical Trials","STUDY_DIRECTOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Reference Study ID Number: CA45905 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. and Canada)",null,"global-roche-genentech-trials@gene.com",{"name":41,"role":36,"phone":38,"phoneExt":38,"email":38},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[43,56,65,76,86,97,107,117,123,128,138,147],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":38},"Children's Healthcare of Atlanta","RECRUITING","Atlanta","Georgia","30342","United States",{"type":51,"coordinates":52},"Point",[53,54],-84.38798,33.749,{"lat":54,"lon":53},{"facility":57,"status":45,"city":58,"state":58,"zip":59,"country":49,"cosmosGeoPoint":60,"geoPoint":64,"contacts":38},"NYU Langone Health","New York","10016",{"type":51,"coordinates":61},[62,63],-74.00597,40.71427,{"lat":63,"lon":62},{"facility":66,"status":45,"city":67,"state":68,"zip":69,"country":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":38},"Royal Children's Hospital","Parkville","Victoria","3052","Australia",{"type":51,"coordinates":72},[73,74],144.95,-37.78333,{"lat":74,"lon":73},{"facility":77,"status":45,"city":78,"state":79,"zip":80,"country":70,"cosmosGeoPoint":81,"geoPoint":85,"contacts":38},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":51,"coordinates":82},[83,84],115.8073,-31.98184,{"lat":84,"lon":83},{"facility":87,"status":45,"city":88,"state":89,"zip":90,"country":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":38},"Children's Hospital ZheJiang University School of Medicine","Hangzhou","Zhejiang","310052","China",{"type":51,"coordinates":93},[94,95],120.16142,30.29365,{"lat":95,"lon":94},{"facility":98,"status":45,"city":99,"state":38,"zip":100,"country":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":38},"National Taiwan University Hospital","Taipei","100","Taiwan",{"type":51,"coordinates":103},[104,105],121.52639,25.05306,{"lat":105,"lon":104},{"facility":108,"status":45,"city":109,"state":38,"zip":110,"country":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":38},"Chulalongkorn University","Bangkok","10330","Thailand",{"type":51,"coordinates":113},[114,115],100.50144,13.75398,{"lat":115,"lon":114},{"facility":118,"status":45,"city":109,"state":38,"zip":119,"country":111,"cosmosGeoPoint":120,"geoPoint":122,"contacts":38},"Siriraj Hospital","10700",{"type":51,"coordinates":121},[114,115],{"lat":115,"lon":114},{"facility":124,"status":45,"city":109,"state":38,"zip":38,"country":111,"cosmosGeoPoint":125,"geoPoint":127,"contacts":38},"Ramathibodi Hospital",{"type":51,"coordinates":126},[114,115],{"lat":115,"lon":114},{"facility":129,"status":45,"city":130,"state":38,"zip":131,"country":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":38},"Birmingham Children's Hospital","Birmingham","B4 6NH","United Kingdom",{"type":51,"coordinates":134},[135,136],-1.89983,52.48142,{"lat":136,"lon":135},{"facility":139,"status":45,"city":140,"state":38,"zip":141,"country":132,"cosmosGeoPoint":142,"geoPoint":146,"contacts":38},"Addenbrooke's Hospital","Cambridge","CB2 0QQ",{"type":51,"coordinates":143},[144,145],0.11667,52.2,{"lat":145,"lon":144},{"facility":148,"status":45,"city":149,"state":38,"zip":150,"country":132,"cosmosGeoPoint":151,"geoPoint":155,"contacts":38},"Sheffield Childrens Hospital","Sheffield","S10 2TH",{"type":51,"coordinates":152},[153,154],-1.4659,53.38297,{"lat":154,"lon":153},{"type":157,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100605109",false,"NCT07158242","A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis","A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis","AMETRINE-PEDS","Inclusion Criteria:\n\n* Bodyweight \\>= 10 kilogram (kg)\n* Confirmed diagnosis of UC\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and\u002For biologic therapies as outlined in the protocol\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)\n* Current diagnosis of Crohn's disease (CD), abdominal\u002Fintrabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Any major surgery within 6 weeks prior to screening or a major planned surgery during the study\n* Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and\u002For chest imaging (X-ray or CT)","ALL","2 Years","17 Years",{"count":169,"type":170},100,"ESTIMATED","INTERVENTIONAL",[173],"PHASE3","This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).",[176],"Moderately to Severely Active Ulcerative Colitis","2026-06-18",{"date":179,"type":180},"2026-06-23","ACTUAL",{"date":182,"type":180},"2026-04-15",{"date":184,"type":170},"2031-03-31",{"name":5,"class":6},12]