[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053821":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":110,"collaborators":37,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":37,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":37,"overallStatus":44,"whyStopped":37,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"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",[42,56,66,77,88,94,99],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":37},"Royal Children's Hospital","RECRUITING","Parkville","Victoria","3052","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],144.95,-37.78333,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":59,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":37},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":51,"coordinates":62},[63,64],115.8073,-31.98184,{"lat":64,"lon":63},{"facility":67,"status":44,"city":68,"state":37,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":37},"National Taiwan University Hospital","Taipei","100","Taiwan","TW",{"type":51,"coordinates":73},[74,75],121.52639,25.05306,{"lat":75,"lon":74},{"facility":78,"status":44,"city":79,"state":37,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":37},"Chulalongkorn University","Bangkok","10330","Thailand","TH",{"type":51,"coordinates":84},[85,86],100.50144,13.75398,{"lat":86,"lon":85},{"facility":89,"status":44,"city":79,"state":37,"zip":90,"country":81,"countryCode":82,"cosmosGeoPoint":91,"geoPoint":93,"contacts":37},"Siriraj Hospital","10700",{"type":51,"coordinates":92},[85,86],{"lat":86,"lon":85},{"facility":95,"status":44,"city":79,"state":37,"zip":37,"country":81,"countryCode":82,"cosmosGeoPoint":96,"geoPoint":98,"contacts":37},"Ramathibodi Hospital",{"type":51,"coordinates":97},[85,86],{"lat":86,"lon":85},{"facility":100,"status":44,"city":101,"state":37,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":37},"Sheffield Childrens Hospital","Sheffield","S10 2TH","United Kingdom","UK",{"type":51,"coordinates":106},[107,108],-1.4659,53.38297,{"lat":108,"lon":107},{"type":111,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100053821","phase-3-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-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":124,"type":125},100,"ESTIMATED","INTERVENTIONAL",[128],"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).",[131],"Moderately to Severely Active Crohns Disease","2026-07-10",{"date":134,"type":135},"2026-07-13","ACTUAL",{"date":137,"type":125},"2026-08-31",{"date":139,"type":125},"2031-05-30",{"name":5,"class":6},7]