[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655645":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":56,"overallOfficials":62,"centralContacts":67,"locations":73,"responsibleParty":90,"collaborators":11,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":11,"overallStatus":112,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},{"fullName":5,"class":6},"Longbio Pharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test.",null,"Week 24",[14,16,18,21,24,28,30,32],{"measure":15,"description":11,"timeFrame":12},"Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test",{"measure":17,"description":11,"timeFrame":12},"Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks",{"measure":19,"description":20,"timeFrame":12},"Change from baseline in the age-specific Food Allergy Quality of Life Questionnaire (FAQLQ).","The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life (HRQL) questionnaires for patients with food allergy. FAQLQ-Teenager Form consists of 23 items and FAQLQ-Adult Form consists of 29 items. The raw score for each item ranges from 0 to 6, which is recorded as 1 to 7. Higher scores indicate greater impairment of food allergy-related quality of life.",{"measure":22,"description":23,"timeFrame":12},"Change from baseline in the age-specific Food Allergy Independent Measure (FAIM).","The FAIM (Food Allergy Independent Measure) consists of 7 items and each item is rated from 0 to 6, and a higher total score reflects a higher perceived risk or probability of experiencing an adverse event. The FAIM can therefore be seen as a patient-reported measure of perceived severity.",{"measure":25,"description":26,"timeFrame":27},"Incidence of Treatment-Emergent Adverse Events (TEAEs) .","Incidence and severity of TEAEs from first dose to end of study are recorded.","Up to approximately 36 weeks",{"measure":29,"description":11,"timeFrame":27},"Serum concentrations of LP-003",{"measure":31,"description":11,"timeFrame":27},"Concentrations of free immunoglobulin E (IgE) and total IgE",{"measure":33,"description":11,"timeFrame":27},"Anti-drug antibodies (ADA), and neutralizing antibodies (Nab)",[35,37],{"measure":36,"description":11,"timeFrame":12},"Change from baseline in individual cut-off values of Basophil Activation Test (BAT).",{"measure":38,"description":11,"timeFrame":12},"Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)",{"allocation":40,"interventionModel":41,"interventionModelDescription":11,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":11,"whoMasked":11},"NONE",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"LP-003 Dose 1","EXPERIMENTAL","Participants will receive subcutaneous injection of LP-003 Injection at Dose 1.",[51],"Biological: LP-003 Injection",{"label":53,"type":48,"description":54,"interventionNames":55},"LP-003 Dose 2","Participants will receive subcutaneous injection of LP-003 Injection at Dose 2.",[51],[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"BIOLOGICAL","LP-003 Injection","s.c. injection, Q8W",[47,53],[63],{"name":64,"affiliation":65,"role":66},"Kai Guan","Peking Union Medical College Hospital","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":11,"email":72},"Jie Yang","CONTACT","+86-021-58372390","yangj@longbiopharma.com",[74],{"facility":65,"status":11,"city":75,"state":76,"zip":11,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Beijing","Beijing Municipality","China","CN",{"type":80,"coordinates":81},"Point",[82,83],116.39723,39.9075,{"lat":83,"lon":82},[86,89],{"name":64,"role":70,"phone":87,"phoneExt":11,"email":88},"+86-010-69151601","dr_guankai@126.com",{"name":64,"role":66,"phone":11,"phoneExt":11,"email":11},{"type":91,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":103,"type":104},12,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110,111],"Food Allergy","Wheat Hypersensitivity","NOT_YET_RECRUITING","2026-09-07",{"date":115,"type":116},"2026-09-11","ACTUAL",{"date":118,"type":104},"2026-09-04",{"date":120,"type":104},"2027-10-15",{"name":122,"class":6},"Longbio Pharma (Suzhou) Co., Ltd.",1]