[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Longbio Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,63,84],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100617076","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-lp-003-injection-in-patients-with-chronic-rhinosinusitis-with-nasal-polyps-crswnp-100617076",false,"NCT07313917","A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","Inclusion Criteria:\n\n1. Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF);\n2. Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender;\n3. Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP);\n4. Persistence of the following symptoms for ≥ 4 weeks prior to the screening\u002Frun-in period:\n\n   * Nasal congestion;\n   * Any one of the other symptoms: mucoid or mucopurulent nasal discharge, head and facial distension\u002Fpain, hyposmia or anosmia;\n5. Nasal Polyp Score (NPS) ≥ 5 points, with each nasal cavity scoring at least ≥ 2 points during the screening\u002Frun-in period and prior to randomization;\n6. Participants report moderate to severe nasal congestion during the screening\u002Frun-in period and prior to randomization:\n\n   * Nasal Congestion Score (NCS) of 2 or 3 points at the screening\u002Frun-in period (Visit 1, V1);\n   * Mean weekly NCS ≥ 2 points prior to randomization;\n7. With bilateral CRSwNP despite prior treatment with systemic corticosteroids (SCS) such as oral corticosteroids (OCS) within 2 years prior to screening; and\u002For has contraindications to SCS treatment or is intolerant to SCS; and\u002For has undergone nasal polypectomy within 6 months prior to screening, with persistent bilateral CRSwNP.\n8. Has been on a stable dosage of intranasal corticosteroids (INCS) for at least 4 weeks prior to screening;\n9. Demonstrates ≥80% adherence to mometasone furoate nasal spray (MFNS) administration during the run-in period (with a minimum of 14 days of use).\n\nExclusion Criteria:\n\n1. Concurrent other nasal diseases or nasal symptoms;\n2. Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring;\n3. Severe infection requiring intravenous antibiotics and\u002For hospitalization within 4 weeks prior to randomization that has not yet resolved, or active infection requiring oral antibiotics within 2 weeks prior to randomization that has not yet resolved; the investigator assesses that enrollment of the participant may pose uncontrollable risks;\n4. Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection;\n5. Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or participants with a history of such infections that have resolved but are assessed by the investigator as likely to recur frequently;\n6. Any severe or unstable disease that the investigator believes may affect the participant's safety during the study and\u002For hinder the participant from completing the study;\n7. Has any severe or unstable disease that, in the investigator's judgment, may affect the safety of the trial participant during the study and\u002For preclude the participant from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, autoimmune, hematological, or psychiatric disorders.\n8. Current or prior receipt of the following treatments:\n\n   * Use of traditional Chinese medicine (TCM) or proprietary Chinese medicines for chronic rhinosinusitis within 1 week prior to screening;\n   * Use of medium- or short-acting systemic corticosteroids (SCS) within 4 weeks prior to randomization, or long-acting SCS within 6 weeks prior to randomization;\n   * Receipt of any systemic monoclonal antibody therapy \\[e.g., Stapokibart, Dupilumab, Mepolizumab, Omalizumab, Tezepelumab, etc.\\] within 10 weeks prior to randomization or within 5 half-lives (whichever is longer);\n   * Use of systemic immunosuppressants within 4 weeks prior to randomization or within 5 half-lives (whichever is longer);\n   * Initiation of leukotriene receptor antagonist (LTRA) therapy within 4 weeks prior to randomization (participants who have been receiving stable-dose LTRA therapy for at least 4 weeks prior to randomization are eligible for enrollment);\n9. For participants with concurrent asthma, the forced expiratory volume in 1 second (FEV1) as a percentage of predicted value ≤ 50% during the screening\u002Frun-in period;\n10. Known allergy or intolerance to any component of the investigational product and\u002For mometasone furoate nasal spray;\n11. Pregnant or lactating females;\n12. Any other conditions that the investigator deems inappropriate for the participant to participate in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.",[27],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","NOT_YET_RECRUITING","2026-02-04",{"date":31,"type":32},"2026-02-06","ACTUAL",{"date":34,"type":21},"2026-01-20",{"date":36,"type":21},"2027-09-30",{"name":38,"class":39},"Longbio Pharma","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100620872","phase-2-efficacy-and-safety-of-lp-005-injection-in-patients-with-complement-mediated-kidney-disease-100620872","NCT07363265","Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease","A Multicenter, Open-label Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease","Inclusion Criteria:\n\n1. Males or females aged 18 to 65 years at screening.\n2. Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg\u002Fm\\^2 (inclusive).\n3. Patients with complement-mediated renal disease.\n4. Females and males of childbearing potential (including the participants' partners) must agree to use effective contraceptive measures during the trial and for 3 months after the trial ends.\n5. Willing to participate in this clinical trial and voluntarily sign the informed consent form; additionally, be assessed by the investigator as being able to fully understand and comply with all planned study procedures and other requirements.\n\nExclusion Criteria:\n\n1. Pregnant or lactating female.\n2. History of meningococcal infection.\n3. Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening.\n4. Other severe, poorly controlled comorbidities within 3 months prior to screening.\n5. Patients with known hypersensitivity to any component of LP-005 or a history of atopic diathesis.\n6. History of malignancy within 5 years prior to screening, except for resected cutaneous basal cell carcinoma, resected cutaneous squamous cell carcinoma, and completely resected carcinoma in situ without evidence of local recurrence or metastasis (e.g., cervical carcinoma in situ or breast carcinoma in situ).\n7. Prior use of any complement inhibitor within 3 months prior to screening or 5 half-lives of the drug, whichever is longer.\n8. Participation in another clinical trial with administration of investigational drug or medical device within 4 weeks prior to screening or 5 half-lives of the administered product, whichever applies.\n9. Any condition that, in the investigator's judgment, may impede study participation, pose a safety risk to the participant, or confound the interpretation of study results.","65 Years",{"count":50,"type":21},46,[24],"This is a multicenter, open-label, proof-of-concept, phase Ⅱ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in patients with complement-mediated renal diseases.",[54],"Complement-mediated Renal Diseases","2026-01-15",{"date":57,"type":32},"2026-01-23",{"date":59,"type":21},"2026-02-02",{"date":61,"type":21},"2029-05-02",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"100619298","phase-2-efficacy-safety-and-pharmacokinetics-of-lp-003-injection-in-allergic-asthma-patients-100619298","NCT07342803","Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients","A Multicenter, Randomized, Double-Blind, Active Drug and Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in the Treatment of Patients With Moderate to Severe Persistent Allergic Asthma.","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years, no gender restriction;\n2. Body weight ≥ 40 kg;\n3. Diagnosed with bronchial asthma for at least 1 year according to the \"Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)\", and diagnosed with allergic asthma according to the \"Chinese Guidelines for the Diagnosis and Treatment of Allergic Asthma (2019 Edition)\" ; At least 1 asthma exacerbation in the year prior to screening (referring to GINA and Chinese guidelines, asthma exacerbation is defined as worsening of asthma symptoms requiring systemic glucocorticoid treatment for at least 3 days, and\u002For multiplying the dose of inhaled glucocorticoids for at least 3 days);\n4. Positive bronchial dilation test within 24 months prior to screening or at the time of screening;\n5. Subjects with at least one positive skin prick test or positive serum specific IgE test result for a relevant allergen within 12 months prior to randomization;\n6. Subjects who have received medium to high dose inhaled corticosteroids (ICS) treatment for at least 8 weeks prior to screening (fluticasone propionate \\>250 μg\u002Fday or equivalent dose of ICS, not exceeding fluticasone propionate 2000 μg\u002Fday or equivalent dose of ICS, as per the \"Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)\"), have maintained stable use for 4 weeks before randomization, with asthma remaining partially controlled or uncontrolled (defined as ACT score ≤ 19);\n7. Combined with at least one other asthma control medication (long-acting β2 receptor agonists (LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), and sustained-release theophylline treatment) and stable use for 4 weeks before randomization ;\n8. At screening, 40% \\\u003C FEV1 \\\u003C 80% of predicted value;\n9. Subjects who have no plans for pregnancy and agree to take effective contraceptive measures during the trial and for 6 months after the last dose of study treatment;\n10. Subjects who voluntarily sign the ICF, are able to understand and correctly fill out the assessment form, correctly use the PEF device and record the patient diary card, and attend follow-up visits as scheduled.Male or female, aged 18 to 75 years.\n\nExclusion Criteria:\n\n1. Allergic to the investigational product and its excipients or Xolair® ;\n2. Coexisting diseases other than asthma that may affect lung function, such as chronic obstructive pulmonary disease (COPD), allergic bronchopulmonary aspergillosis (ABPA), and bronchiectasis, which, in the investigator's judgment, may place the subject at inappropriate risk or affect the assessment of study results;\n3. Patients who have severe or uncontrolled diseases of the liver, kidneys, gastrointestinal tract, cardiovascular and cerebrovascular systems, hematopoietic system, urogenital system, endocrine system, nervous system, immune system, etc.;\n4. Clinically significant infection history within 4 weeks prior to randomization, as assessed by the investigator, affecting patient evaluation;\n5. Major surgery within 4 weeks prior to randomization or planned surgical procedures during the study period, or treatments that the investigator believes may affect patient evaluation;\n6. Known parasitic infection within 6 months prior to randomization;\n7. History of malignancy diagnosed within 5 years prior to screening;\n8. Clinically significant abnormalities in laboratory tests during the screening period and baseline, deemed unsuitable for participation by the investigator ;\n9. Positive test for human immunodeficiency virus (HIV) antibodies at screening, or positive for treponema pallidum antibodies (except RPR or TRUST negative), or positive for hepatitis B surface antigen (except HBV-DNA below the detection limit of the site), or positive for hepatitis B core antibody (except HBV-DNA below the detection limit of the site), or positive for hepatitis C virus (HCV) antibodies (except HCV RNA below the detection limit of the site);\n10. Still smoking or having quit smoking for less than 6 months at screening, or a history of smoking ≥10 pack-years \\[Smoking Index (pack-years) = daily smoking amount (packs) × smoking duration (years), 1 pack = 20 cigarettes\\];\n11. Used biological agents such as monoclonal antibodies, including investigational biological agents, within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer);\n12. Received systemic immunosuppressants or systemic glucocorticoids (dose equivalent to prednisone \\>10 mg\u002Fday) for inflammatory or autoimmune diseases (such as rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, etc.) within 8 weeks prior to screening or within 5 half-lives of the drug (whichever is longer);\n13. Specific allergen immunotherapy conducted within 3 months prior to screening;\n14. Live (attenuated) virus\u002Fbacterial vaccines administered or intravenous immunoglobulin used within 4 weeks prior to screening;\n15. Participation in other drug clinical trials within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening;\n16. History of drug abuse, substance abuse, and\u002For excessive alcohol consumption within 1 year prior to screening;\n17. Pregnant or breastfeeding women;\n18. Any other condition that makes the subject unsuitable for participation in the trial as assessed by the investigator.",{"count":71,"type":21},200,[24],"This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.",[75],"Allergic Asthma","RECRUITING","2026-01-05",{"date":55,"type":32},{"date":80,"type":32},"2025-01-25",{"date":82,"type":21},"2029-09-30",{"name":38,"class":39},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":40},"100613405","phase-2-efficacy-safety-and-pharmacokinetics-of-lp-005-injection-in-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-100613405","NCT07266155","Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","A Phase Ⅱ Extension Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Inclusion Criteria:\n\n1. Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).\n2. Patients who have completed the treatment of the Phase Ⅱ clinical study of LP-005 Injection and are assessed by the investigator as eligible for continued treatment with LP-005 Injection.\n3. Patients who have received Neisseria meningitidis vaccine and Streptococcus pneumoniae vaccine in accordance with the requirements of previous studies; if the vaccine protection period does not cover the treatment duration of this study, patients must agree to receive booster vaccination in a timely manner in accordance with the vaccine administration guidelines and the requirements of local vaccination institutions.\n4. Females and males of childbearing potential (including male subjects with female partners) must agree to use effective contraceptive measures from the start of the trial until 3 months after the end of the trial.\n\nExclusion Criteria:\n\n1. Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug.\n2. Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment.\n3. Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment.\n4. Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.",{"count":92,"type":21},30,[24],"This is an extension study for patients who have completed a prior P10-LP005-02 clinical study. The aim of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).",[96],"Paroxysmal Nocturnal Hemoglobinuria","2025-11-24",{"date":99,"type":32},"2025-12-05",{"date":99,"type":21},{"date":102,"type":21},"2028-05-01",{"name":38,"class":39},""]