[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ige-mediated-food-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ige-mediated-food-allergy":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"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":20,"type":21},576,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"IgE-Mediated Food Allergy","Peanut Allergy","Cow Milk Allergy","Egg Allergy",[32,33,34,35,36],"IgE-mediated food allergy,","peanut allergy,","milk allergy,","egg allergy,","remibrutinib","NOT_YET_RECRUITING","2026-08-12",{"date":40,"type":41},"2026-08-17","ACTUAL",{"date":43,"type":21},"2026-09-11",{"date":45,"type":21},"2029-12-31",{"name":47,"class":48},"Novartis Pharmaceuticals","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100648885","fasc-fish-allergy-in-spanish-children---a-study-of-new-cases-of-fish-allergy-in-children-and-adolescents-100648885","NCT07727148","FASC: Fish Allergy in Spanish Children - A Study of New Cases of Fish Allergy in Children and Adolescents","IgE-Mediated Fish Allergy in Spanish Children and Adolescents: A Multicenter Prospective Study of New-Onset Cases and Sensitization Profiles.","FASC","Inclusion Criteria:\n\n* Children and adolescents aged 0 to 17 years (up to 18 years of age).\n* First clinical episode compatible with IgE-mediated fish allergy.\n* Evidence of allergic sensitization demonstrated by at least one of the following:\n* Positive skin prick test (wheal diameter ≥3 mm compared with the negative control); or\n* Serum specific IgE ≥0.35 kUA\u002FL to at least one fish species or fish allergen component.\n* Written informed consent obtained from the parent(s) or legal guardian(s), and assent from participants aged 12 years or older, when applicable.\n\nExclusion Criteria:\n\n* Age ≥18 years.\n* Non-IgE-mediated fish allergy (e.g., fish-induced FPIES).\n* Severe dermographism, chronic urticaria, or severe atopic dermatitis preventing reliable interpretation of skin prick testing.\n* Inability to complete the diagnostic procedures required by the study.\n* Absence of informed consent or, when applicable, participant assent.","17 Years",{"count":59,"type":21},120,"OBSERVATIONAL","Fish allergy is one of the leading causes of food-induced allergic reactions in children, but the clinical presentation and patterns of sensitization vary considerably among patients and geographical regions. This prospective multicenter observational study aims to characterize children and adolescents with newly diagnosed IgE-mediated fish allergy in Spain.\n\nClinical information, diagnostic test results, and molecular sensitization profiles will be collected using standardized procedures across participating centers. Molecular allergy assessment will include component-resolved diagnostics to evaluate sensitization to major fish allergens and other relevant allergenic protein families. The study will also assess disease severity, quality of life, and regional differences in sensitization patterns.\n\nThe results are expected to improve the understanding of pediatric fish allergy in Spain and contribute to more accurate diagnosis, risk assessment, and personalized management of affected patients.",[63,64,27],"Fish Allergy","Food Hypersensitivity",[63,66,67,68,69,70,71,72,73,74,75,76],"Pediatric Allergy","Food Allergy","IgE-Mediated Allergy","Component-Resolved Diagnostics","Molecular Allergology","Specific IgE","Children","Adolescents","Anaphylaxis","Food Challenge","Quality of Life","2026-07-22",{"date":79,"type":41},"2026-07-27",{"date":81,"type":21},"2026-10-01",{"date":83,"type":21},"2028-06-30",{"name":85,"class":86},"Carmelo Escudero","OTHER",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100619219","phase-4-steroid-use-in-treatment-of-allergic-reactions-to-food-100619219","NCT07341776","Steroid Use in Treatment of Allergic Reactions to Food","Evaluation of Emergency Medication in Children With Food Allergies: a Prospective, Randomized Clinical Multicenter Study Comparing Antihistamines Versus Antihistamines Plus Steroids in a Controlled Setting of Oral Food Challenges in Children.","SAFARI","Inclusion Criteria:\n\n* suspected or confirmed IgE-mediated food allergy\n\nExclusion Criteria:\n\n* Non-IgE mediated food allergies\n* Non-food allergies\n* Age outside the specified range\n* Contraindications for an oral food challenge or oral steroid use within one week before the challenge.","6 Months","18 Years",{"count":98,"type":21},160,[100],"PHASE4","In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. In addition to adrenaline and antihistamines, steroids are frequently administered in German-speaking Switzerland. However, it is unclear whether steroids are really helpful in this situation. To investigate this, the investigators are comparing two groups: one group receives additional steroids, and the other does not. Which treatment a participant receives is decided randomly, like flipping a coin. The study takes place during a pre-scheduled provocation test at the clinic. If an allergic reaction occurs, the usual emergency medications will be administered. Doctors will closely monitor how the reaction develops. No additional tests or visits are required. The results of this study could help improve allergy treatment in the future.",[103,74,104,105],"Anaphylactic Reaction","Allergy in Children","IgE Mediated Food Allergy","RECRUITING","2026-01-26",{"date":109,"type":41},"2026-01-27",{"date":107,"type":41},{"date":112,"type":21},"2026-12",{"name":114,"class":86},"Johannes Trueck",2]