[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053821":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":11,"studyPopulation":11,"armGroups":54,"interventions":65,"overallOfficials":75,"centralContacts":79,"locations":87,"responsibleParty":156,"collaborators":11,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":160,"sex":166,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":11,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":11,"overallStatus":90,"whyStopped":11,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)",null,"At Week 52",{"measure":14,"description":11,"timeFrame":12},"Percentage of Participants With Endoscopic Response",[16,19,21,23,26,28,30,32,34,36,38,41],{"measure":17,"description":11,"timeFrame":18},"Percentage of Participants With Clinical Remission","At Week 12 and Week 52",{"measure":20,"description":11,"timeFrame":18},"Percentage of Participants With Clinical Response",{"measure":22,"description":11,"timeFrame":18},"Percentage of Participants With CDAI Remission",{"measure":24,"description":11,"timeFrame":25},"Change From Baseline in Fecal Calprotectin","Baseline, Week 12 and Week 52",{"measure":27,"description":11,"timeFrame":25},"Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score",{"measure":29,"description":11,"timeFrame":12},"Percentage of Participants With Endoscopic Remission",{"measure":31,"description":11,"timeFrame":12},"Percentage of Participants With Corticosteroid-Free Clinical Remission",{"measure":33,"description":11,"timeFrame":18},"Percentage of Participants with Maintenance of Remission",{"measure":35,"description":11,"timeFrame":12},"Percentage of Participants With Histologic Improvement",{"measure":37,"description":11,"timeFrame":12},"Percentage of Participants With Ulcer-Free Endoscopy",{"measure":39,"description":11,"timeFrame":40},"Incidence and Severity of Adverse Events (AEs)","Up to Approximately 5.5 Years",{"measure":42,"description":11,"timeFrame":40},"Serum Concentration of Afimkibart",{"allocation":44,"interventionModel":45,"interventionModelDescription":11,"primaryPurpose":46,"observationalModel":11,"timePerspective":11,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":11,"whoMasked":49},"QUADRUPLE",[50,51,52,53],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Afimkibart Dose A","EXPERIMENTAL","Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.",[60],"Drug: Afimkibart",{"label":62,"type":57,"description":63,"interventionNames":64},"Afimkibart Dose B","Participants will receive Afimkibart IV followed by Afimkibart SC.",[60],[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","Afimkibart","Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.",[56,62],[72,73,74],"RO7790121","PF-06480605","RVT-3101",[76],{"name":77,"affiliation":5,"role":78},"Clinical Trials","STUDY_DIRECTOR",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":11,"email":84},"Reference Study ID Number: CP45906 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":86,"role":82,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[88,102,112,123,134,140,145],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":11},"Royal Children's 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University","Bangkok","10330","Thailand","TH",{"type":97,"coordinates":130},[131,132],100.50144,13.75398,{"lat":132,"lon":131},{"facility":135,"status":90,"city":125,"state":11,"zip":136,"country":127,"countryCode":128,"cosmosGeoPoint":137,"geoPoint":139,"contacts":11},"Siriraj Hospital","10700",{"type":97,"coordinates":138},[131,132],{"lat":132,"lon":131},{"facility":141,"status":90,"city":125,"state":11,"zip":11,"country":127,"countryCode":128,"cosmosGeoPoint":142,"geoPoint":144,"contacts":11},"Ramathibodi Hospital",{"type":97,"coordinates":143},[131,132],{"lat":132,"lon":131},{"facility":146,"status":90,"city":147,"state":11,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Sheffield Childrens Hospital","Sheffield","S10 2TH","United Kingdom","UK",{"type":97,"coordinates":152},[153,154],-1.4659,53.38297,{"lat":154,"lon":153},{"type":157,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":170,"type":171},100,"ESTIMATED","INTERVENTIONAL",[174],"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).",[177],"Moderately to Severely Active Crohns Disease","2026-07-10",{"date":180,"type":181},"2026-07-13","ACTUAL",{"date":183,"type":171},"2026-08-31",{"date":185,"type":171},"2031-05-30",{"name":5,"class":6},7]