[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wheat-hypersensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wheat-hypersensitivity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100655645","phase-2-a-study-to-evaluate-the-safety-efficacy-pharmacokinetic-and-pharmacodynamic-characteristics-of-lp-003-injection-in-participants-with-wheat-allergy-100655645",false,"NCT07816432","A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy","A Multicenter, Randomized, Open-Label Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy","Inclusion Criteria:\n\n* Aged ≥12 years and ≤60 years, male or female;\n* History of wheat or gluten allergy;\n* Positive skin prick test (SPT) to the allergen (wheat or gluten), and\u002For positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat\u002Fgluten extract or ω 5 gliadin) at screening or within three months prior to screening;\n* Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening;\n* No plan to conceive and agree to use effective contraceptive measures throughout the trial period;\n* The participant and\u002For parent\u002Flegal representative understands and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* Allergic to LP-003 Injection or its excipients;\n* Uncontrolled asthma or severe asthma at screening;\n* Any severe disease;\n* History of severe allergic reactions to wheat or gluten;\n* Not enough washing-out period for previous therapy before the food exercise challenge at screening.","ALL","12 Years","60 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat dependent exercise induced anaphylaxis. Its primary objective is to explore and preliminarily evaluate the efficacy of LP-003 Injection in the participants with Wheat dependent exercise induced anaphylaxis, as well as to investigate its safety, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.",[27,28],"Food Allergy","Wheat Hypersensitivity","NOT_YET_RECRUITING","2026-09-07",{"date":32,"type":33},"2026-09-11","ACTUAL",{"date":35,"type":21},"2026-09-04",{"date":37,"type":21},"2027-10-15",{"name":39,"class":40},"Longbio Pharma (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100518806","comparison-efficacy-between-two-different-frequency-of-maintenance-dose-oral-immunotherapy-100518806","NCT06035328","Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy","Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy","Inclusion Criteria:\n\n* Age 5-18 years old\n* Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test\n* Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT\n\nExclusion Criteria:\n\n* Patient with low dose OIT protocol\n* Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease;\n* Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab)\n* Patients with a developmental problem or mental disorder\n* Active eosinophilic gastrointestinal disease in the past 2 years\n* Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers\n* Pregnancy or lactation\n* Patient who could not visit clinic as protocol","5 Years","18 Years",{"count":52,"type":21},64,[54],"NA","Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times\u002Fweek dose during one year maintenance phase of wheat OIT",[28,57],"Immunotherapy",[28,57,59],"Short term unresponsiveness","RECRUITING","2025-05-06",{"date":63,"type":33},"2025-05-09",{"date":65,"type":33},"2023-07-01",{"date":67,"type":21},"2027-03-22",{"name":69,"class":70},"Mahidol University","OTHER"]