A Phase 2 interventional study of LP-003 Injection and Placebo Injection in Peanut Allergies, sponsored by Longbio Pharma (Suzhou) Co., Ltd.. Not yet recruiting. Open to participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Longbio Pharma (Suzhou) Co., Ltd. · Phase 2, Interventional, and Treatment
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 of 100 mg or less of peanut protein.
Participants who meet screening criteria will be assigned to Part A or Part B based on baseline body weight and total IgE according to the FDA-approved omalizumab dosing table. Part A will include approximately 20 participants who are not eligible for treatment with omalizumab, based on the omalizumab dosing table; this will include participants with baseline total IgE greater than 2000 IU/mL. Part B will include approximately 60 participants who are eligible for treatment with omalizumab, per the omalizumab dosing table. Within each part, participants will be randomized in a 2:2:1 ratio to receive LP-003 dose level 1 LP-003 dose level 2, or placebo by subcutaneous injection once every 8 weeks. Randomization will be stratified by age group, with groups defined as younger than 18 years or equal to or greater than 18 years old.
The study includes a screening period of up to 4 weeks, a 24-week double-blind treatment period, a 24-week blinded extension treatment period, and an approximately 32-week blinded follow-up period. During the double-blind treatment period, participants will receive their assigned study intervention and will undergo efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments according to the study schedule. The primary efficacy assessment will be performed at Week 24 using a supervised double-blind, placebo-controlled food challenge. The primary endpoint is the proportion of participants who can consume a single dose of at least 600 mg of peanut protein without dose-limiting symptoms.
Participants who complete the Week 24 visit will enter a blinded extension treatment period and receive LP-003 300 mg every 8 weeks for three doses. A final double-blind, placebo-controlled food challenge will be performed at Week 48 to determine efficacy. After the Week 48 visit, participants will enter a blinded follow-up period of approximately 32 weeks to allow drug clearance and continued safety monitoring. During the follow-up period, safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments will continue.
Secondary efficacy assessments include the maximum tolerated peanut dose without symptoms, symptom-free response rates at different peanut challenge dose levels, use of rescue medication, and the proportion of participants who can tolerate higher peanut protein challenge doses at Weeks 24 and 48. Safety will be assessed by monitoring adverse events, serious adverse events, adverse events of special interest, laboratory tests, vital signs, physical examinations, electrocardiograms, injection-site reactions, and other clinically relevant findings. Exploratory assessments include skin prick test responses, peanut allergen-specific IgE, serum total IgE and free IgE, LP-003 plasma concentrations and Food Allergy Quality of Life Questionnaire results.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Longbio Pharma (Suzhou) Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Briefing Inclusion Criteria:
Briefing 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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive 300 mg LP-003 Injection given via subcutaneous injection to the participant, Q8W, for a total of 3 doses for each participant. Each dose will be divided into 3 injections (2 mL/per injection).
Drug: LP-003 Injection
Participants in this arm will receive 600 mg LP-003 Injection will be given via subcutaneous injection to the participant, Q8W, for a total of 3 doses for each participant. Each dose will be divided into 3 injections (2 mL/per injection).
Drug: LP-003 Injection
Participants in this arm will be given via subcutaneous injection to the participant, Q8W, for a total of 3 doses for each participant. Each dose will be divided into 3 injections.
Drug: Placebo Injection
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.
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).
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).
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)
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).
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).
Participant consumption of ≥1 dose of 2000 mg at Week 48.
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 48 (Day 337).
Incident Rate of Adverse Events for Study Participants
All adverse events experienced by participants will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA). The number of participants with AE and incidence of all treatment emergent adverse events will be summarized by System Organ Class (SOC), Preferred Term (PT), and severity grade.
Time frame: Measured from time of consent through study follow up period, Week 80 (Day 561).
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for May 2029, 32 months later.
Of 18 phase 2 interventional studies under Peanut Hypersensitivity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 32 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: LP-003
Longbio Pharma (Suzhou) Co., Ltd. →