Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients
ConditionPeanut Allergies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-55
SponsorLongbio Pharma (Suzhou) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 12 years and ≤ 55 years, regardless of gender.
Documented medical history of allergy to peanuts or peanut-containing foods.
Peanut sIgE ≥ 0.35 kUA/L at Screening Visit 1.
Positive SPT for peanut allergens at Screening Visit 1.
Disqualifiers
History of hypersensitivity to LP-003 and its excipients and other biologics (i.e. Omalizumab or to other murine, chimeric or human antibodies).
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.).
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.
Uncontrolled asthma at the screening according to the 2025 GINA Severe Asthma Guide.
Trial design
Design model
Parallel
Treatments tested in this trial
LP-003 Injection
DrugThe 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 Injection
DrugPlacebo is a sterile injectable solution matched to LP-003 for appearance, formulation, and administration, with 0 mg of active ingredient.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Arm 1: 300mg LP-003 Injection GroupExperimental treatment 1 intervention
Group B: Arm 2: 600mg LP-003 Injection GroupExperimental treatment 1 intervention
Group C: Arm 3: Placebo Injection GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Patients Without Dose Limiting Symptoms
The proportion of participants in each group who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled food challenge (DBPCFC) conducted in a controlled clinic setting. Dose-limiting symptoms are those that in the view of the principal investigator indicate a true allergic reaction
Time frame
From initial administration of the investigational product (Day1) up to and including Week 24 (Day 141).Secondary outcomes
1
The Maximum Tolerated Dose (MTD) of Peanut Protein
The MTD of peanut protein consumed by participants without symptoms determined by the percentage of participants symptom free for each dose of peanut protein administered (30 mg, 100 mg, 300 mg, 600 mg, 1000 mg and/or 2000 mg).
Time frame
At study visit Week 24 (Day 141).2
Participant consumption of ≥600 mg of peanut protein without dose-limiting symptoms.
The proportion of participants in each group who successfully consume a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the double-blind placebo-controlled oral food challenge (DBPCFC) conducted in a controlled clinic setting.
Time frame
Study visit Week 48 (Day 337)3
The Maximum Tolerated Dose (MTD) of Peanut Protein at Week 48.
The MTD of peanut protein consumed by participants without symptoms determined by the percentage of participants symptom free for each dose of peanut protein administered (30 mg, 100 mg, 300 mg, 600 mg, 1000 mg and/or 2000 mg).
Time frame
Measured at study visit Week 48 (Day 337).4
Participant consumption of ≥1 dose of 2000 mg at Week 24.
The proportion of participants who successfully consume ≥1 dose of 2000 mg of peanut protein without dose-limiting symptoms during the DBPCFC conducted in a controlled clinic setting.
Time frame
Measured at Week 24 (Day 141).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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