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.
Aged ≥12 years and ≤60 years, male or female;
History of wheat or gluten allergy;
Positive skin prick test (SPT) to the allergen (wheat or gluten), and/or positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat/gluten extract or ω 5 gliadin) at screening or within three months prior to screening;
Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening;
Allergic to LP-003 Injection or its excipients;
Uncontrolled asthma or severe asthma at screening;
Any severe disease;
History of severe allergic reactions to wheat or gluten;
Parallel
LP-003 Injection
Biological/Vaccines.c. injection, Q8W
Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test.
Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test
Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks
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.
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.
Change from baseline in individual cut-off values of Basophil Activation Test (BAT).
Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)
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