A Phase 2 interventional study of LP-003 Injection in Food Allergy and Wheat Hypersensitivity, sponsored by Longbio Pharma (Suzhou) Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Longbio Pharma (Suzhou) Co., Ltd. · Phase 2, Interventional, and Treatment
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.
20 studies on the registry are indexed under Wheat Hypersensitivity; 5 are open to participants now.
This study's planned enrollment of 12 is below the median of 46 across 14 interventional studies indexed under Wheat Hypersensitivity.
Browse Wheat Hypersensitivity studies →Longbio Pharma (Suzhou) Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Compared within Wheat Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive subcutaneous injection of LP-003 Injection at Dose 1.
Biological: LP-003 Injection
Participants will receive subcutaneous injection of LP-003 Injection at Dose 2.
Biological: LP-003 Injection
s.c. injection, Q8W
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
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
Change from baseline in individual cut-off values of Basophil Activation Test (BAT).
Time frame: Week 24
Change from baseline in the positive sensitization rate of allergen-specific IgE (sIgE)
Time frame: Week 24
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: LP-003