[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053821":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":106,"collaborators":37,"id":108,"slug":37,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":37,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":37,"overallStatus":44,"whyStopped":37,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"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",[42,55,65,75,85,91,96],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":37},"Royal Children's Hospital","RECRUITING","Parkville","Victoria","3052","Australia",{"type":50,"coordinates":51},"Point",[52,53],144.95,-37.78333,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":58,"zip":59,"country":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":37},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":50,"coordinates":61},[62,63],115.8073,-31.98184,{"lat":63,"lon":62},{"facility":66,"status":44,"city":67,"state":37,"zip":68,"country":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":37},"National Taiwan University Hospital","Taipei","100","Taiwan",{"type":50,"coordinates":71},[72,73],121.52639,25.05306,{"lat":73,"lon":72},{"facility":76,"status":44,"city":77,"state":37,"zip":78,"country":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":37},"Chulalongkorn University","Bangkok","10330","Thailand",{"type":50,"coordinates":81},[82,83],100.50144,13.75398,{"lat":83,"lon":82},{"facility":86,"status":44,"city":77,"state":37,"zip":87,"country":79,"cosmosGeoPoint":88,"geoPoint":90,"contacts":37},"Siriraj Hospital","10700",{"type":50,"coordinates":89},[82,83],{"lat":83,"lon":82},{"facility":92,"status":44,"city":77,"state":37,"zip":37,"country":79,"cosmosGeoPoint":93,"geoPoint":95,"contacts":37},"Ramathibodi Hospital",{"type":50,"coordinates":94},[82,83],{"lat":83,"lon":82},{"facility":97,"status":44,"city":98,"state":37,"zip":99,"country":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":37},"Sheffield Childrens Hospital","Sheffield","S10 2TH","United Kingdom",{"type":50,"coordinates":102},[103,104],-1.4659,53.38297,{"lat":104,"lon":103},{"type":107,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100053821",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":119,"type":120},100,"ESTIMATED","INTERVENTIONAL",[123],"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).",[126],"Moderately to Severely Active Crohns Disease","2026-07-10",{"date":129,"type":130},"2026-07-13","ACTUAL",{"date":132,"type":120},"2026-08-31",{"date":134,"type":120},"2031-05-30",{"name":5,"class":6},7]