A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

Phase 2Not Yet RecruitingNCT07816432

Longbio Pharma (Suzhou) Co., Ltd.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Food Allergy Wheat Hypersensitivity

Interventions

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test.

Time frame: Week 24

Secondary Outcomes

Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test

Time frame: Week 24

Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks

Time frame: Week 24

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.

Time frame: Week 24

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.

Time frame: Week 24

Incidence of Treatment-Emergent Adverse Events (TEAEs) .

Incidence and severity of TEAEs from first dose to end of study are recorded.

Time frame: Up to approximately 36 weeks

Serum concentrations of LP-003

Time frame: Up to approximately 36 weeks

Concentrations of free immunoglobulin E (IgE) and total IgE

Time frame: Up to approximately 36 weeks

Anti-drug antibodies (ADA), and neutralizing antibodies (Nab)

Time frame: Up to approximately 36 weeks

A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts