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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Jie Yang
- Telefonnummer: 86-021-58372390
- E-post: tclinchuang@longbiopharma.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1: 300mg LP-003 Injection Group
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).
|
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.
|
|
Eksperimentell: Arm 2: 600mg LP-003 Injection Group
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).
|
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.
|
|
Eksperimentell: Arm 3: Placebo Injection Group
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.
|
Placebo is a sterile injectable solution matched to LP-003 for appearance, formulation, and administration, with 0 mg of active ingredient.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Patients Without Dose Limiting Symptoms
Tidsramme: From initial administration of the investigational product (Day1) up to and including Week 24 (Day 141).
|
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
|
From initial administration of the investigational product (Day1) up to and including Week 24 (Day 141).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Maximum Tolerated Dose (MTD) of Peanut Protein
Tidsramme: At study visit Week 24 (Day 141).
|
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).
|
At study visit Week 24 (Day 141).
|
|
Participant consumption of ≥600 mg of peanut protein without dose-limiting symptoms.
Tidsramme: Study visit Week 48 (Day 337)
|
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.
|
Study visit Week 48 (Day 337)
|
|
The Maximum Tolerated Dose (MTD) of Peanut Protein at Week 48.
Tidsramme: Measured at study visit Week 48 (Day 337).
|
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 48 (Day 337).
|
|
Participant consumption of ≥1 dose of 2000 mg at Week 24.
Tidsramme: Measured at Week 24 (Day 141).
|
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 at Week 24 (Day 141).
|
|
Participant consumption of ≥1 dose of 2000 mg at Week 48.
Tidsramme: Measured at Week 48 (Day 337).
|
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 at Week 48 (Day 337).
|
|
Incident Rate of Adverse Events for Study Participants
Tidsramme: Measured from time of consent through study follow up period, Week 80 (Day 561).
|
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 from time of consent through study follow up period, Week 80 (Day 561).
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P10-LP003-10
Legemiddel- og utstyrsinformasjon, studiedokumenter
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