Food AllergyPhase 2NCT07816432
A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy
A Phase 2 study testing LP-003 Injection in people with Food Allergy and Wheat Hypersensitivity, run by Longbio Pharma (Suzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Food Allergy, Wheat Hypersensitivity
- What is being tested?
- LP-003 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2026to 15 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Kai Guan, +86-010-69151601, dr_guankai@126.com
Kai Guan
About this study
Official title: 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.
- Conditions
- Food Allergy, Wheat Hypersensitivity
- Being tested
- LP-003 Injection
- Medical subject headings
- Food Hypersensitivity, Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-003 InjectionBiological
s.c. injection, Q8W
| Study group | Role | What they receive |
|---|---|---|
| LP-003 Dose 1 | Experimental | Participants will receive subcutaneous injection of LP-003 Injection at Dose 1. Receives: Biological: LP-003 Injection |
| LP-003 Dose 2 | Experimental | Participants will receive subcutaneous injection of LP-003 Injection at Dose 2. Receives: Biological: LP-003 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who consumed a cumulative dose of 24 g gluten protein without dose limiting symptoms in the food exercise challenge test.
Measured: 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
Measured: Week 24
Proportion of participants who used any rescue medication (e.g., albuterol, epinephrine, or others) within 24 weeks
Measured: 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.
Measured: 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.
Measured: Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs) .
Incidence and severity of TEAEs from first dose to end of study are recorded.
Measured: Up to approximately 36 weeks
Serum concentrations of LP-003
Measured: Up to approximately 36 weeks
Concentrations of free immunoglobulin E (IgE) and total IgE
Measured: Up to approximately 36 weeks
Anti-drug antibodies (ADA), and neutralizing antibodies (Nab)
Measured: Up to approximately 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start4 Sep 2026 (estimated)
- Primary completion16 Jul 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Guan, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816432
- Sponsor's protocol ID
- P10-LP003-06
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07816432
- Acronym / sponsor ID
- P10-LP003-06
- Conditions
- Food Allergy, Wheat Hypersensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Longbio Pharma (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP-003 Dose 1 | Experimental | Biological: LP-003 InjectionParticipants will receive subcutaneous injection of LP-003 Injection at Dose 1. |
| LP-003 Dose 2 | Experimental | Biological: LP-003 InjectionParticipants will receive subcutaneous injection of LP-003 Injection at Dose 2. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-003 Injections.c. injection, Q8W | Biological | LP-003 Dose 1, LP-003 Dose 2 |
Primary outcome
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
8 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).
Time frame: Week 24
Change from baseline in the age-specific Food Allergy Independent Measure (FAIM).
Time frame: Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs) .
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai Guan principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP-003 Injection in people with Food Allergy and Wheat Hypersensitivity, run by Longbio Pharma (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Yang (+86-021-58372390, yangj@longbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.