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

NCT07816432 | Not Yet Recruiting Phase 2

• 1 other identifier: P10-LP003-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Wheat Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Change from baseline in the age-specific Food Allergy Independent Measure (FAIM).

  Week 24

• Incidence of Treatment-Emergent Adverse Events (TEAEs) .

  Up to approximately 36 weeks

Other Outcomes (2)

• Change from baseline in individual cut-off values of Basophil Activation Test (BAT).

  Week 24

• Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)

  Week 24

Study Arms (2)

LP-003 Dose 1

EXPERIMENTAL

Participants will receive subcutaneous injection of LP-003 Injection at Dose 1.

Biological: LP-003 Injection

LP-003 Dose 2

EXPERIMENTAL

Participants will receive subcutaneous injection of LP-003 Injection at Dose 2.

Biological: LP-003 Injection

Interventions

LP-003 Injection BIOLOGICAL

s.c. injection, Q8W

LP-003 Dose 1; LP-003 Dose 2

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Longbio Pharma (Suzhou) Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Food Hypersensitivity; Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kai Guan

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yang

CONTACT

+86-021-58372390; yangj@longbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 4, 2026
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)