Food Allergy, Wheat Hypersensitivity
Conditions
Brief summary
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.
Interventions
BIOLOGICALLP-003 Injection
s.c. injection, Q8W
Sponsors
Longbio Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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; * No plan to conceive and agree to use effective contraceptive measures throughout the trial period; * The participant and/or parent/legal representative understands and voluntarily signs the informed consent form.
Exclusion criteria
* 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; * Not enough washing-out period for previous therapy before the food exercise challenge at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test. | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test | Week 24 | — |
| Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks | Week 24 | — |
| Change from baseline in the age-specific Food Allergy Quality of Life Questionnaire (FAQLQ). | Week 24 | 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). | Week 24 | 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. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) . | Up to approximately 36 weeks | Incidence and severity of TEAEs from first dose to end of study are recorded. |
| Serum concentrations of LP-003 | Up to approximately 36 weeks | — |
| Concentrations of free immunoglobulin E (IgE) and total IgE | Up to approximately 36 weeks | — |
| Anti-drug antibodies (ADA), and neutralizing antibodies (Nab) | Up to approximately 36 weeks | — |
Countries
China
Contacts
CONTACTJie Yang
PRINCIPAL_INVESTIGATORKai Guan
Peking Union Medical College Hospital
Outcome results
None listed