[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Longbio Pharma (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100655645","phase-2-a-study-to-evaluate-the-safety-efficacy-pharmacokinetic-and-pharmacodynamic-characteristics-of-lp-003-injection-in-participants-with-wheat-allergy-100655645",false,"NCT07816432","A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy","A Multicenter, Randomized, Open-Label Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy","Inclusion Criteria:\n\n* Aged ≥12 years and ≤60 years, male or female;\n* History of wheat or gluten allergy;\n* Positive skin prick test (SPT) to the allergen (wheat or gluten), and\u002For positive allergen-specific immunoglobulin E (sIgE) to food allergen (crude wheat\u002Fgluten extract or ω 5 gliadin) at screening or within three months prior to screening;\n* Dose-limiting symptoms occurred at a cumulative dose of ≤24 g gluten protein during the food-exercise challenge test at screening;\n* No plan to conceive and agree to use effective contraceptive measures throughout the trial period;\n* The participant and\u002For parent\u002Flegal representative understands and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* Allergic to LP-003 Injection or its excipients;\n* Uncontrolled asthma or severe asthma at screening;\n* Any severe disease;\n* History of severe allergic reactions to wheat or gluten;\n* Not enough washing-out period for previous therapy before the food exercise challenge at screening.","ALL","12 Years","60 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat dependent exercise induced anaphylaxis. Its primary objective is to explore and preliminarily evaluate the efficacy of LP-003 Injection in the participants with Wheat dependent exercise induced anaphylaxis, as well as to investigate its safety, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.",[27,28],"Food Allergy","Wheat Hypersensitivity","NOT_YET_RECRUITING","2026-09-07",{"date":32,"type":33},"2026-09-11","ACTUAL",{"date":35,"type":21},"2026-09-04",{"date":37,"type":21},"2027-10-15",{"name":39,"class":40},"Longbio Pharma (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100653353","phase-2-efficacy-safety-and-pharmacokinetics-of-lp-003-in-peanut-allergic-patients-100653353","NCT07785063","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","Briefing Inclusion Criteria:\n\n1. Age ≥ 12 years and ≤ 55 years, regardless of gender.\n2. Documented medical history of allergy to peanuts or peanut-containing foods.\n3. Peanut sIgE ≥ 0.35 kUA\u002FL at Screening Visit 1.\n4. Positive SPT for peanut allergens at Screening Visit 1.\n5. 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.\n6. Participants agree to avoid exposure to the corresponding allergens and any other peanut foods that may cause allergies throughout the study period.\n7. 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.\n8. Participants and\u002For their parents\u002Flegal guardians are able to understand and voluntarily sign the informed consent form.\n\nBriefing Exclusion Criteria:\n\n1. History of hypersensitivity to LP-003 and its excipients and other biologics (i.e. Omalizumab or to other murine, chimeric or human antibodies).\n2. Hypersensitivity or suspected\u002Fknown allergy to any of the matrix components used within the material for oral food challenge (excluding the test allergens peanut etc.).\n3. 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.\n4. Uncontrolled asthma at the screening according to the 2025 GINA Severe Asthma Guide.\n5. Current use of oral, IM, or IV corticosteroid, tricyclic antidepressants, or β-blockers (oral or topical).\n6. Received oral, IM, or IV corticosteroids or tricyclic antidepressants for an indication other than asthma\u002Fwheezing within 30 days prior to screening.\n7. Current or previous history of a mast cell disorder, including mastocytosis.\n8. Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or DBPCFCs.\n9. 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).\n10. Participated in other clinical trials of medications within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer).\n11. 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\\]).\n12. 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.\n13. Participants with severe peanut-related eczema, herpetiform dermatitis, eosinophilic esophagitis, eosinophilic gastrointestinal disorders, colitis, peanut FPIES, or other gastrointestinal diseases.\n14. 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.\n15. History of malignancy was diagnosed within the past 5 years.\n16. Pregnant or breastfeeding women, or participants planning to become pregnant during the study period.\n17. Any other circumstances that the investigator considers may make the participant unsuitable for participation in the trial.","55 Years",{"count":51,"type":21},80,[24],"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.\n\nThe 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.",[55],"Peanut Allergies","2026-08-20",{"date":58,"type":33},"2026-08-25",{"date":60,"type":21},"2026-09",{"date":62,"type":21},"2029-11",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100637568","phase-2-efficacy-and-safety-of-lp-005-injection-in-patients-with-moderate-to-severe-periodontitis-100637568","NCT07603713","Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive), with no restriction on sex.\n2. Clinically diagnosed with moderate to severe (Stage II or III) periodontitis according to the 2018 International Classification of Periodontal and Peri-Implant Diseases. participants must have at least 2 non-adjacent natural teeth (excluding third molars) in the dentition with a Probing Depth (PD) of 5 to 8 mm (inclusive), and at least 1 site per tooth with a BI score \\> 2.\n3. Participants and their partners must agree to practice effective non-pharmacological contraception from the time of signing the Informed Consent Form (ICF) until 3 months after the study completion. For female participants of childbearing potential, a negative pregnancy test result is required within 7 days prior to the first dose.\n4. Voluntary participation in the trial and signed approval of the ICF.\n\nExclusion Criteria:\n\n1. At the time of screening, the target tooth and\u002For adjacent teeth (as determined by the investigator to affect the target tooth) exhibit periapical periodontitis, pericoronitis, or combined pulp-periodontal lesions; or the participant has orthodontic appliances (including fixed lingual retainers, etc.);\n2. At screening, the target tooth and\u002For adjacent teeth (as determined by the investigator to affect the target tooth) are found by the investigator to have severe caries or caries requiring immediate treatment;\n3. At screening, the participant has a periodontal or dental abscess, or a tumor of the oral soft or hard tissues;\n4. Participants who have previously undergone periodontal surgery on the target teeth and\u002For adjacent teeth (as determined by the investigator to affect the target teeth), or who have undergone subgingival scaling and root planning (SRP) within 6 months prior to screening;\n5. Participants with a history of Neisseria meningitidis infection;\n6. Participants with a history of splenectomy or congenital asplenia;\n7. Participants with impaired immune function (e.g., HIV infection, neutropenia, complement deficiency, etc.);\n8. Participants with autoimmune diseases that the investigator determines may interfere with the evaluation of the study disease, such as Sjögren's syndrome, systemic lupus erythematosus, psoriasis, rheumatoid arthritis, etc.;\n9. Participants with poorly controlled blood pressure at screening, such as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n10. Participants with glycated hemoglobin (HbA1c) \\>7.5% or severe diabetic complications at screening;\n11. Participants with severe or poorly controlled systemic diseases at screening, as determined by the investigator, such as respiratory, gastrointestinal, cardiovascular, hematological, urological, neurological, or psychiatric disorders;\n12. Participants who have continuously taken medications deemed by the investigator to interfere with the study within 1 month prior to screening, such as nifedipine, phenytoin, or anticoagulants (e.g., warfarin);\n13. Participants who have received systemic antibiotic therapy within 3 months prior to screening;\n14. Participants who have taken nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids on a long-term basis (≥3 times per week) prior to screening;\n15. Participants with any of the following laboratory test results at the time of screening:\n\n    * ALT or AST \\> 2.5 times the upper limit of normal (ULN) or serum total bilirubin \\> 1.5 times ULN;\n    * Serum creatinine \\> 1.5 times the upper ULN;\n    * International Normalized Ratio (INR) ≥ 1.5 times ULN, or activated partial thromboplastin time (APTT) ≥ 1.5 times ULN (excluding participants currently receiving anticoagulant therapy);\n    * Platelet count (PLT) \\\u003C 100 × 10⁹\u002FL;\n16. Participants who test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab) at screening;\n17. Participants with a history of malignant tumors within 5 years prior to screening;\n18. Participants with a history of heavy smoking (≥10 cigarettes per day) within 12 months prior to screening;\n19. Participants with known allergies to any drugs or materials used during surgery;\n20. Pregnant or breastfeeding women;\n21. Participants who have participated in other clinical trials within 30 days prior to screening or who plan to participate in other clinical trials during the study period;\n22. Participants assessed by the investigator as having other conditions rendering them unsuitable for participation in the clinical study.","18 Years","70 Years",{"count":74,"type":21},100,[24],"This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the clinical efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple local injections of different doses of LP-005 injection in patients with moderate-to-severe periodontitis, and to investigate changes in biomarker levels.",[78],"Periodontitis","2026-05-16",{"date":81,"type":33},"2026-05-22",{"date":83,"type":21},"2026-05-01",{"date":85,"type":21},"2027-03-23",{"name":39,"class":40},""]