Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients

This study will evaluate the safety and efficacy of LP-003 for an increasing the amount of peanut protein that people with a peanut allergy can tolerate without having allergic symptoms. The study will include participants 12 to 55 years of age with a confirmed peanut allergy. Participants will be randomly assigned to receive LP-003 or placebo. LP-003 will be given by an injection under the skin (subcutaneous) once every 8 weeks during the first 24 weeks of treatment. Participants will not know the treatment they are receiving until the end of the study.

The primary efficacy endpoints will be the proportion of participants in each group who successfully consume a single dose of ≥600 mg of peanut protein during a supervised double-blind, placebo-controlled food challenge at Week 24. Participants who complete the 24 weeks will continue for another 24 weeks in a blinded (participants will not know what treatment they are on) extension period, followed by a blinded follow-up period for continued safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. The total study duration for each participant is approximately 84 weeks.

Briefing Inclusion Criteria:

1. Age ≥ 12 years and ≤ 55 years, regardless of gender.
2. Documented medical history of allergy to peanuts or peanut-containing foods.
3. Peanut sIgE ≥ 0.35 kUA/L at Screening Visit 1.
4. Positive SPT for peanut allergens at Screening Visit 1.
5. A positive peanut DBPCFC at baseline (Screening Visit 2) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
6. Participants agree to avoid exposure to the corresponding allergens and any other peanut foods that may cause allergies throughout the study period.
7. Participants have no plans for pregnancy and agree to use effective contraception during the trial and for until 6 months after the last administration of the investigational product.
8. Participants and/or their parents/legal guardians are able to understand and voluntarily sign the informed consent form.

Briefing Exclusion Criteria:

1. History of hypersensitivity to LP-003 and its excipients and other biologics (i.e. Omalizumab or to other murine, chimeric or human antibodies).
2. Hypersensitivity or suspected/known allergy to any of the matrix components used within the material for oral food challenge (excluding the test allergens peanut etc.).
3. History of severe allergic reactions or anaphylaxis (anaphylactic shock) to participant-specific foods (i.e. peanut) in this study, defined as neurological damage or requiring intubation.
4. Uncontrolled asthma at the screening according to the 2025 GINA Severe Asthma Guide.
5. Current use of oral, IM, or IV corticosteroid, tricyclic antidepressants, or β-blockers (oral or topical).
6. Received oral, IM, or IV corticosteroids or tricyclic antidepressants for an indication other than asthma/wheezing within 30 days prior to screening.
7. Current or previous history of a mast cell disorder, including mastocytosis.
8. Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or DBPCFCs.
9. Participants who have used immune modulate biologics (e.g., Omalizumab, Dupixent, anti-IL-5) within 6 months prior to screening or within 5 half-lives (whichever is longer).
10. Participated in other clinical trials of medications within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer).
11. Participants who have undergone immunotherapy for any food related to the study within the past 6 months (e.g., oral immunotherapy [OIT], sublingual immunotherapy [SLIT]).
12. Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reach maintenance dosing). Note: individuals on stable maintenance dosing can be enrolled.
13. Participants with severe peanut-related eczema, herpetiform dermatitis, eosinophilic esophagitis, eosinophilic gastrointestinal disorders, colitis, peanut FPIES, or other gastrointestinal diseases.
14. Significant screening laboratory abnormalities, serious medical conditions (e.g., severe arrhythmia, uncontrolled hypertension, severe pulmonary disease), or lab abnormalities judged by the investigator to jeopardize safe study participation.
15. History of malignancy was diagnosed within the past 5 years.
16. Pregnant or breastfeeding women, or participants planning to become pregnant during the study period.
17. Any other circumstances that the investigator considers may make the participant unsuitable for participation in the trial.