[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615885":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":144,"collaborators":37,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":37,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":37,"overallStatus":44,"whyStopped":37,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"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],"RO7790121","PF-06480605","RVT-3101",[29],{"name":30,"affiliation":5,"role":31},"Clinical Trials","STUDY_DIRECTOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Reference Study ID Number: CP45906 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)",null,"global-roche-genentech-trials@gene.com",{"name":40,"role":35,"phone":37,"phoneExt":37,"email":37},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[42,55,67,77,89,100,111,122,128,133],{"facility":43,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":37},"NYU Langone Health","RECRUITING","New York","10016","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-74.00597,40.71427,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":37},"Royal Children's Hospital","Parkville","Victoria","3052","Australia","AU",{"type":50,"coordinates":63},[64,65],144.95,-37.78333,{"lat":65,"lon":64},{"facility":68,"status":44,"city":69,"state":70,"zip":71,"country":60,"countryCode":61,"cosmosGeoPoint":72,"geoPoint":76,"contacts":37},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":50,"coordinates":73},[74,75],115.8073,-31.98184,{"lat":75,"lon":74},{"facility":78,"status":44,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":37},"CECIP - Centro de Estudos Clínicos do Interior Paulista","Jaú","São Paulo","17201-130","Brazil","BR",{"type":50,"coordinates":85},[86,87],-48.55778,-22.29639,{"lat":87,"lon":86},{"facility":90,"status":44,"city":91,"state":37,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":37},"FAICIC Clinical Research","Veracruz","91900","Mexico","MX",{"type":50,"coordinates":96},[97,98],-96.1429,19.18095,{"lat":98,"lon":97},{"facility":101,"status":44,"city":102,"state":37,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":37},"National Taiwan University Hospital","Taipei","100","Taiwan","TW",{"type":50,"coordinates":107},[108,109],121.52639,25.05306,{"lat":109,"lon":108},{"facility":112,"status":44,"city":113,"state":37,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":37},"Chulalongkorn University","Bangkok","10330","Thailand","TH",{"type":50,"coordinates":118},[119,120],100.50144,13.75398,{"lat":120,"lon":119},{"facility":123,"status":44,"city":113,"state":37,"zip":124,"country":115,"countryCode":116,"cosmosGeoPoint":125,"geoPoint":127,"contacts":37},"Siriraj Hospital","10700",{"type":50,"coordinates":126},[119,120],{"lat":120,"lon":119},{"facility":129,"status":44,"city":113,"state":37,"zip":37,"country":115,"countryCode":116,"cosmosGeoPoint":130,"geoPoint":132,"contacts":37},"Ramathibodi Hospital",{"type":50,"coordinates":131},[119,120],{"lat":120,"lon":119},{"facility":134,"status":44,"city":135,"state":37,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":37},"Sheffield Childrens Hospital","Sheffield","S10 2TH","United Kingdom","UK",{"type":50,"coordinates":140},[141,142],-1.4659,53.38297,{"lat":142,"lon":141},{"type":145,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100615885","a-study-to-assess-the-pharmacokinetics-effectiveness-and-safety-of-afimkibart-for-induction-and-maintenance-therapy-in-children-with-moderately-to-severely-active-crohns-disease-100615885",false,"NCT07298421","A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease","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 Crohn's Disease","SIBERITE-PEDS","Inclusion Criteria:\n\n* Body weight \\>= 10 kilogram (kg)\n* Active CD confirmed by endoscopy (ileocolonoscopy)\n* Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \\>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \\>=6 (or \\>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy\n* Inadequate response, loss of response, and\u002For intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and\u002For immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)\n* History of \\>= 3 bowel resections: \\> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum\n* Current diagnosis of ulcerative colitis (UC), abdominal\u002Fintraabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.\n* Symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Current diagnosis or suspicion of primary sclerosing cholangitis","ALL","2 Years","17 Years",{"count":158,"type":159},100,"ESTIMATED","INTERVENTIONAL",[162],"PHASE3","This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).",[165],"Moderately to Severely Active Crohns Disease","2026-08-06",{"date":168,"type":169},"2026-08-10","ACTUAL",{"date":171,"type":159},"2026-08-31",{"date":173,"type":159},"2031-05-30",{"name":5,"class":6},10]