Longbio Pharma (Suzhou) Co., Ltd.
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.
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 multiregional clinical study designed to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of LP-003 in participants with peanut allergy. The study will enroll approximately 80 participants aged 12 to 55 years with confirmed peanut allergy, including a clinical history of peanut allergy, positive peanut-specific IgE or Ara h 2-specific IgE, positive peanut skin prick test, and dose-limiting symptoms during a baseline double-blind, placebo-controlled food challenge at a single dose o…
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 an…
The active ingredient of LP-003 Injection is a humanized anti-IgE monoclonal antibody. There are two dose groups, 300mg and 600mg: each administered as a subcutaneous injection site, Q8W.
Placebo is a sterile injectable solution matched to LP-003 for appearance, formulation, and administration, with 0 mg of active ingredient.