[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651918":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":57,"centralContacts":61,"locations":56,"responsibleParty":68,"collaborators":56,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":56,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":56,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":98,"whyStopped":56,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":56},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,15,20,24,28,32,36,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Sub-study 1- LOU064","EXPERIMENTAL","Participants with peanut allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.",[13,14],"Drug: Remibrutinib","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Sub-study 1- Placebo","PLACEBO_COMPARATOR","Participants with peanut allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.",[14],{"label":21,"type":10,"description":22,"interventionNames":23},"Sub-study 2- LOU064","Participants with cow's milk allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.",[13,14],{"label":25,"type":17,"description":26,"interventionNames":27},"Sub-study 2- Placebo","Participants with cow's milk allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.",[14],{"label":29,"type":10,"description":30,"interventionNames":31},"Sub-study 3- LOU064","Participants with hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.",[13,14],{"label":33,"type":17,"description":34,"interventionNames":35},"Sub-study 3- Placebo","Participants with hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 24), followed by open-label remibrutinib treatment through Week 52.",[14],{"label":37,"type":10,"description":38,"interventionNames":39},"Sub-study 4- LOU064","Participants with peanut, cow's milk, and hen's egg allergy will receive remibrutinib during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52.",[13,14],{"label":41,"type":17,"description":42,"interventionNames":43},"Sub-study 4- Placebo","Participants with peanut, cow's milk, and hen's egg allergy will receive matching placebo during the double-blind treatment period (up to Week 4), followed by open-label remibrutinib treatment through Week 52.",[14],[45,52],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Remibrutinib","Oral administration of remibrutinib.",[9,21,29,37],[51],"LOU064",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Placebo","Oral administration of placebo.",[9,16,21,25,29,33,37,41],null,[58],{"name":59,"affiliation":59,"role":60},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[62,66],{"name":59,"role":63,"phone":64,"phoneExt":56,"email":65},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":59,"role":63,"phone":67,"phoneExt":56,"email":65},"+41613241111",{"type":69,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100651918","phase-3-a-52-week-study-of-remibrutinib-in-ige-mediated-food-allergy-100651918",false,"NCT07768371","A 52-week Study of Remibrutinib in IgE-mediated Food Allergy","A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy","Inclusion Criteria:\n\n* Signed informed consent and\u002For assent (where applicable) must be obtained prior to study participation. Participant (and parent\u002Flegal guardian for adolescents) must be able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he\u002Fshe must be re-consented (ICF) at the next study visit.\n* Male or female participants who are 12 to 65 years of age, inclusive, at the time of signing informed consent\u002Fassent.\n* Positive allergen-specific (peanut, milk, or egg), IgE (≥ 0.35 kUA\u002FL) at Screening Visit 1.\n* Positive Skin Prick Testing (SPT) for peanut, milk, or egg at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control.\n* A positive DBPCFC at baseline (Screening Visit 2), defined as the occurrence of dose-limiting symptoms at a single dose:\n\n  * ≤ 100 mg of peanut allergen protein\n  * ≤ 300 mg for milk or egg allergen protein\n* Participants must be able and willing to participate in the DBPCFC and must be willing to continue avoiding exposure to peanut, milk (cooked and uncooked), or egg (cooked and uncooked) and any other foods that they are allergic to throughout this study.\n\nExclusion Criteria:\n\n* Previous use of remibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.\n* History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.\n* Hypersensitivity or intolerance to any of the matrix components used within the material for the DBPCFC.\n* Any occurrence of dose-limiting symptoms against placebo allergen at baseline DBPCFC (Screening Visit Part 1 and\u002For Part 2).\n* Medical examination, medical conditions or laboratory findings that, in the opinion of the investigator, renders the participant unsuitable for the study.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","12 Years","65 Years",{"count":81,"type":82},576,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk (\"milk\", cooked and uncooked) or hen's egg (\"egg\", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo.",[88,89,90,91],"IgE-Mediated Food Allergy","Peanut Allergy","Cow Milk Allergy","Egg Allergy",[93,94,95,96,97],"IgE-mediated food allergy,","peanut allergy,","milk allergy,","egg allergy,","remibrutinib","NOT_YET_RECRUITING","2026-08-12",{"date":101,"type":102},"2026-08-17","ACTUAL",{"date":104,"type":82},"2026-09-11",{"date":106,"type":82},"2029-12-31",{"name":59,"class":6}]