Peanut AllergiesPhase 2NCT07785063
Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients
A Phase 2 study testing LP-003 Injection in people with Peanut Allergies, run by Longbio Pharma (Suzhou) Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Peanut Allergies
- What is being tested?
- LP-003 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Briefing Inclusion Criteria:
- 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.
- 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.
- Participants agree to avoid exposure to the corresponding allergens and any other peanut foods that may cause allergies throughout the study period.
- 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.
- Participants and/or their parents/legal guardians are able to understand and voluntarily sign the informed consent form.
Briefing Exclusion Criteria:
- 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.
- Current use of oral, IM, or IV corticosteroid, tricyclic antidepressants, or β-blockers (oral or topical).
- Received oral, IM, or IV corticosteroids or tricyclic antidepressants for an indication other than asthma/wheezing within 30 days prior to screening.
- Current or previous history of a mast cell disorder, including mastocytosis.
- Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or DBPCFCs.
- 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).
- Participated in other clinical trials of medications within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer).
- 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]).
- 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.
- Participants with severe peanut-related eczema, herpetiform dermatitis, eosinophilic esophagitis, eosinophilic gastrointestinal disorders, colitis, peanut FPIES, or other gastrointestinal diseases.
- 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.
- History of malignancy was diagnosed within the past 5 years.
- Pregnant or breastfeeding women, or participants planning to become pregnant during the study period.
- Any other circumstances that the investigator considers may make the participant unsuitable for participation in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Peanut Allergies
- Being tested
- LP-003 Injection, Placebo Injection
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-003 InjectionDrug
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 InjectionDrug
Placebo is a sterile injectable solution matched to LP-003 for appearance, formulation, and administration, with 0 mg of active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 300mg LP-003 Injection Group | Experimental | 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). Receives: Drug: LP-003 Injection |
| Arm 2: 600mg LP-003 Injection Group | Experimental | 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). Receives: Drug: LP-003 Injection |
| Arm 3: Placebo Injection Group | Experimental | 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. Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From initial administration of the investigational product (Day1) up to and including Week 24 (Day 141).
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured from time of consent through study follow up period, Week 80 (Day 561).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785063
- Sponsor's protocol ID
- P10-LP003-10
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No