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

September 7, 2026 updated by: Longbio Pharma (Suzhou) Co., Ltd.

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Kai Guan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LP-003 Dose 1
Participants will receive subcutaneous injection of LP-003 Injection at Dose 1.
Biological: LP-003 Injection
s.c. injection, Q8W
Experimental: LP-003 Dose 2
Participants will receive subcutaneous injection of LP-003 Injection at Dose 2.
Biological: LP-003 Injection
s.c. injection, Q8W

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated cumulative dose of gluten protein (the highest dose without dose-limiting symptoms) in the food exercise challenge test
Time Frame: Week 24
Week 24
Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks
Time Frame: Week 24
Week 24
Change from baseline in the age-specific Food Allergy Quality of Life Questionnaire (FAQLQ).
Time Frame: 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.
Week 24
Change from baseline in the age-specific Food Allergy Independent Measure (FAIM).
Time Frame: 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.
Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs) .
Time Frame: Up to approximately 36 weeks
Incidence and severity of TEAEs from first dose to end of study are recorded.
Up to approximately 36 weeks
Serum concentrations of LP-003
Time Frame: Up to approximately 36 weeks
Up to approximately 36 weeks
Concentrations of free immunoglobulin E (IgE) and total IgE
Time Frame: Up to approximately 36 weeks
Up to approximately 36 weeks
Anti-drug antibodies (ADA), and neutralizing antibodies (Nab)
Time Frame: Up to approximately 36 weeks
Up to approximately 36 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline in individual cut-off values of Basophil Activation Test (BAT).
Time Frame: Week 24
Week 24
Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Longbio Pharma (Suzhou) Co., Ltd.

Investigators

  • Principal Investigator: Kai Guan, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 4, 2026

Primary Completion (Estimated)

July 16, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

September 7, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-LP003-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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