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No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[43,57,66,78,88,100,111,122,128,133,144,153],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":38},"Children's Healthcare of Atlanta","RECRUITING","Atlanta","Georgia","30342","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-84.38798,33.749,{"lat":55,"lon":54},{"facility":58,"status":45,"city":59,"state":59,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":38},"NYU Langone Health","New York","10016",{"type":52,"coordinates":62},[63,64],-74.00597,40.71427,{"lat":64,"lon":63},{"facility":67,"status":45,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":38},"Royal Children's Hospital","Parkville","Victoria","3052","Australia","AU",{"type":52,"coordinates":74},[75,76],144.95,-37.78333,{"lat":76,"lon":75},{"facility":79,"status":45,"city":80,"state":81,"zip":82,"country":71,"countryCode":72,"cosmosGeoPoint":83,"geoPoint":87,"contacts":38},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":52,"coordinates":84},[85,86],115.8073,-31.98184,{"lat":86,"lon":85},{"facility":89,"status":45,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":38},"Children's Hospital ZheJiang University School of Medicine","Hangzhou","Zhejiang","310052","China","CN",{"type":52,"coordinates":96},[97,98],120.16142,30.29365,{"lat":98,"lon":97},{"facility":101,"status":45,"city":102,"state":38,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":38},"National Taiwan University Hospital","Taipei","100","Taiwan","TW",{"type":52,"coordinates":107},[108,109],121.52639,25.05306,{"lat":109,"lon":108},{"facility":112,"status":45,"city":113,"state":38,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":38},"Chulalongkorn University","Bangkok","10330","Thailand","TH",{"type":52,"coordinates":118},[119,120],100.50144,13.75398,{"lat":120,"lon":119},{"facility":123,"status":45,"city":113,"state":38,"zip":124,"country":115,"countryCode":116,"cosmosGeoPoint":125,"geoPoint":127,"contacts":38},"Siriraj Hospital","10700",{"type":52,"coordinates":126},[119,120],{"lat":120,"lon":119},{"facility":129,"status":45,"city":113,"state":38,"zip":38,"country":115,"countryCode":116,"cosmosGeoPoint":130,"geoPoint":132,"contacts":38},"Ramathibodi Hospital",{"type":52,"coordinates":131},[119,120],{"lat":120,"lon":119},{"facility":134,"status":45,"city":135,"state":38,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":38},"Birmingham Children's Hospital","Birmingham","B4 6NH","United Kingdom","UK",{"type":52,"coordinates":140},[141,142],-1.89983,52.48142,{"lat":142,"lon":141},{"facility":145,"status":45,"city":146,"state":38,"zip":147,"country":137,"countryCode":138,"cosmosGeoPoint":148,"geoPoint":152,"contacts":38},"Addenbrooke's Hospital","Cambridge","CB2 0QQ",{"type":52,"coordinates":149},[150,151],0.11667,52.2,{"lat":151,"lon":150},{"facility":154,"status":45,"city":155,"state":38,"zip":156,"country":137,"countryCode":138,"cosmosGeoPoint":157,"geoPoint":161,"contacts":38},"Sheffield Childrens Hospital","Sheffield","S10 2TH",{"type":52,"coordinates":158},[159,160],-1.4659,53.38297,{"lat":160,"lon":159},{"type":163,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100605109","phase-3-a-study-to-evaluate-the-pharmacokinetics-safety-and-efficacy-of-afimkibart-ro7790121-in-children-with-moderately-to-severely-active-ulcerative-colitis-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":176,"type":177},100,"ESTIMATED","INTERVENTIONAL",[180],"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).",[183],"Moderately to Severely Active Ulcerative Colitis","2026-06-18",{"date":186,"type":187},"2026-06-23","ACTUAL",{"date":189,"type":187},"2026-04-15",{"date":191,"type":177},"2031-03-31",{"name":5,"class":6},12]