[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TJ Biopharma Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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},"100608938","phase-3-a-phase-iii-clinical-study-to-evaluate-the-efficacy-safety-and-tolerability-of-plonmarlimab-in-subjects-with-relapsedrefractory-rheumatic-and-immunologic-disease-associated-haemophagocytic-lymphohistiocytosis-also-known-as-macrophage-activation-syndrome-mas-100608938",false,"NCT07208058","A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed\u002FRefractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])","An Open-label, Single-arm, Multicenter, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed\u002FRefractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])","Inclusion Criteria:\n\n* Age: 16 to 80 years (inclusive), of any gender.\n* The subject is willing to participate in this study and voluntarily signs the informed consent form. For minor subjects aged 16 years (inclusive) to less than 18 years, written informed consent must be signed by both the subject and the subject's legal guardian.\n* Diagnosed with a rheumatic and immunological disease.\n* Diagnosed with haemophagocytic lymphohistiocytosis (HLH) according to the HLH-2004 diagnostic criteria (excluding molecular diagnosis)\n* No response to\u002For dependence on\u002Fintolerance to\u002For worsening during high-dose corticosteroid therapy. High-dose corticosteroid therapy: at least 1.5-2.0 mg\u002Fkg\u002Fd of prednisone or its equivalent dose for 3 consecutive days, including methylprednisolone pulse therapy (15-30 mg\u002Fkg\u002Fd, maximum dose 1 g\u002Fd, for 3-5 days).\n\nExclusion Criteria:\n\n* Confirmed or suspected primary haemophagocytic lymphohistiocytosis (pHLH).\n* HLH induced by infection (including but not limited to EBV-HLH) or treatment (including but not limited to drugs such as CAR-T cells, TCEs, ADCs).\n* History of other active neoplasm malignant within 5 years prior to screening, with the exception of successfully treated cutaneous basal cell or squamous cell carcinoma, or localised neoplasms that have been adequately treated with curative intent, including but not limited to, uterine carcinoma in situ, breast cancer in situ, thyroid cancer, etc.; asymptomatic, localised prostate cancer confirmed to have no metastasis and not requiring treatment, etc. Prior to receiving the investigational drug, an assessment by an oncology specialist is required to clarify the current status of the neoplasm malignant and to rule out the possibility of HLH secondary to the neoplasm malignant.\n* History of allergy to any component of the investigational drug.\n* Lung disorder: including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, alveolar proteinosis, pulmonary granulomatosis, etc., and abnormal pulmonary function tests: forced vital capacity (FVC) \\\u003C80% of predicted value, or FEV1\u002FFVC \\\u003C70%, etc.; or the investigator's comprehensive assessment concludes that the subject has a pre-existing lung disease that significantly affects pulmonary function and is unsuitable for participation in this clinical study.\n* Cardiovascular disorder: history of acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multifocal frequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation), etc., within the last 6 months; New York Heart Association (NYHA) functional class III-IV.\n* Infection: Presence of an infection deemed uncontrollable by the investigator during the screening period \\[including but not limited to tuberculosis, active syphilis infection, viral infection (EBV, CMV, COVID-19, active hepatitis B, active hepatitis C, human immunodeficiency virus), other bacterial infections (including but not limited to atypical mycobacteria, Shigella, Salmonella, Campylobacter, etc.)\\].\n* Abnormal renal function: creatinine (Cr) or urea\u002Fblood urea nitrogen (BUN) test value \\>1.5 times the upper limit of normal (ULN); or eGFR \\\u003C60 mL\u002Fmin during the screening period, calculated using the MDRD formula: eGFR \\[mL\u002F(min × 1.73 m2)\\] = 186 × serum creatinine (mg\u002FdL)-1.154 × age (years)-0.203 × (0.742 if female) × 1.233.\n* Haematological diseases: Subjects with a past or current history of haematological diseases (including but not limited to, myelofibrosis, aplastic anaemia, leukaemia, lymphoma, etc.).\n* Surgery or other conditions: Planned surgery or any other medical history, laboratory test abnormal, or other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.\n* Transplant: History of major organ transplant (e.g., heart, lung, kidney, liver) or haematopoietic stem cell\u002Fbone marrow transplant.\n* Other diseases: Subject currently has a clinically significant and clinically unstable or inadequately controlled acute or chronic disease (e.g., acute pneumonia, pulmonary arterial hypertension, diabetic ketoacidosis, pancreatitis acute, etc.).\n* Pregnant or lactating women.\n* Participation in any clinical trial (including investigational vaccines) treatment or use of an invasive investigational medical device within 3 months prior to enrolment, or currently enrolled in an interventional study.\n* Received live vaccine within 30 days prior to screening.\n* Evidence of alcohol abuse within 3 months prior to screening or current abuse, identified through medical history inquiry.\n* Other conditions that, in the investigator's opinion, make the subject unsuitable for participation in this clinical study. For example, any condition that may increase the risks associated with the subject's participation in the study, or may interfere with the evaluation of the investigational drug or confound the interpretation of the study results.","ALL","16 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A study designed to evaluate the efficacy, safety, immunogenicity, PK, and PD characteristics of Plonmarlimab in patients with relapsed\u002Frefractory rheumatic and immunologic disease-associated MAS, and to explore biomarkers related to the efficacy of Plonmarlimab.",[27],"Relapsed\u002FRefractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2025-11-21",{"date":36,"type":21},"2027-11-30",{"name":38,"class":39},"TJ Biopharma Co., Ltd.","INDUSTRY",15,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100627774","phase-2-a-study-to-evaluate-the-efficacysafetytolerabilitypharmacokineticsand-immunogenicty-of-plonmarlimab-in-subjects-with-acute-gouty-arthritis-100627774","NCT07453004","A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis","A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Punarlimab in Subjects With Acute Gouty Arthritis","Inclusion Criteria:\n\n* Subjects aged ≥18 years, regardless of gender.\n* Subjects are willing to participate in this study and voluntarily sign the informed consent form.\n* Meet the 2015 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) gout classification criteria.\n* Experienced ≥3 episodes of acute gout flare within the 12 months prior to baseline (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).\n* Subjects have experienced an acute gout flare within 5 days prior to administration of the investigational product (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).\n* Contraindicated, intolerant, or inadequately responsive to colchicine and\u002For non-steroidal anti-inflammatory drugs (NSAIDs) (determination based on patient history, referral records, etc., will be made by the investigator).\n* Baseline pain intensity assessment in the most severely affected joint by the subject using a 0-100 mm Visual Analogue Scale (VAS) is ≥50 mm.\n* Subjects may or may not be receiving urate-lowering therapy. If planning to continue urate-lowering therapy during the study, it must have been at a stable dose for ≥2 weeks prior to baseline.\n* Subjects (including their partners) have no pregnancy plans from the screening period until 90 days after dosing and voluntarily agree to use effective contraception.\n\nExclusion Criteria:\n\n* Secondary gout caused by various etiologies (e.g., gout induced by chemotherapy, judged by the investigator based on the subject's medical history, referral records, etc.).\n* History of hypersensitivity to any component of the investigational product or to similar biological agents.\n* Contraindication to compound betamethasone therapy.\n* Presence of other rheumatic diseases besides gout that may interfere with interpretation of results, including but not limited to rheumatoid arthritis, infectious\u002Fsuppurative arthritis, traumatic arthritis, etc.\n* Pulmonary diseases including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary alveolar proteinosis, pulmonary granulomatosis, etc., or any underlying pulmonary disease that significantly impairs pulmonary function as assessed by the investigator, making the subject unsuitable for this clinical study.\n* Cardiovascular diseases: history of acute myocardial infarction, unstable angina, severe arrhythmia (multifrequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation) within the past 6 months; New York Heart Association (NYHA) functional Class III-IV (see Appendix 4). Presence of long QT syndrome or QTc interval \\> 450 msec (male) or \\> 470 msec (female) during screening.\n* History of malignancy within the past 5 years (regardless of treatment), except for successfully treated basal cell or squamous cell carcinoma of the skin.\n* Other diseases: subjects with a past and\u002For current clinically significant, unstable, or uncontrolled acute or chronic disease unrelated to gout (e.g., acute pneumonia, pulmonary hypertension, diabetic ketoacidosis, acute pancreatitis, etc.), or scheduled medical\u002Fsurgical procedures; or any condition that places the subject at undue risk or impairs the ability to participate voluntarily.\n* Infections: presence of any known acute, chronic, or recurrent active infection during screening (e.g., tuberculosis, syphilis, HIV, HBV, HCV, Pneumocystis jirovecii, CMV, HSV, VZV, atypical mycobacteria, Histoplasma capsulatum, Salmonella infection, genital herpes, osteomyelitis, urinary tract infection, etc.).\n* Abnormal hepatic and renal function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) \\> 2 × upper limit of normal (ULN); alkaline phosphatase (ALP) or total bilirubin (TBIL) \\> 1.5 × ULN; creatinine (Cr) or blood urea nitrogen (BUN) \\> 1.5 × ULN; or eGFR ≤ 60 mL\u002Fmin\u002F1.73 m² prior to screening (calculated using the MDRD formula, see Appendix 9).\n* Hematological diseases or abnormal routine blood tests: subjects with a past or current hematological disease including but not limited to myelofibrosis, aplastic anemia, leukemia, lymphoma, etc.; hemoglobin \\\u003C 90 g\u002FL, platelet count \\\u003C 80×10⁹\u002FL, white blood cell or neutrophil count below the lower limit of normal with clinically significant abnormality judged by the investigator.\n* Planned surgery or any other medical history (e.g., recent sepsis), laboratory abnormality, or other condition judged by the investigator to render the subject ineligible for this study.\n* History of organ transplantation.\n* Pregnant or lactating female subjects.\n* Participation in any interventional clinical trial (including investigational vaccines) or use of an invasive investigational medical device within 3 months prior to enrollment, or current enrollment in another interventional study.\n* Administration of live (attenuated) vaccine within 30 days prior to screening. Inability to receive intramuscular injection (e.g., subjects on anticoagulants, thrombocytopenia, known bleeding disorders such as idiopathic thrombocytopenic purpura).\n* Drug abuse detected by urine drug screening, including morphine, ketamine, tetrahydrocannabinol, methamphetamine, MDMA, cocaine.\n* Alcohol abuse within 3 months prior to screening, defined as alcohol consumption \\> 14 units per week (1 unit = 17.5 mL or 14 g pure alcohol; 1 unit ≈ 35 mL of 50% spirits or 350 mL of 5% beer), or unwillingness to abstain from alcohol or alcohol-containing products during the trial.\n* Any other condition deemed by the investigator to render the subject unsuitable for this clinical study, including any condition that may increase study-related risk, interfere with evaluation of the investigational product, or confound interpretation of study results.","18 Years",{"count":50,"type":21},170,[52],"PHASE2","This is a multi center,randomized,double-blind,double-dummy,active-controlled study,and planned enrollment of 120-170 subjects,an interim analysis will be conducted after first 60 subjects complete the 72 -hour pain Visual Analogue Scale(VAS) assessment following their initial dose.Based on the analysis result，the sample size may be adjusted, and 1or 2 group(s）of the investigational drug will be selected to continue enrollment along with the active comparator group.The goal is to evaluate the efficacy of plonmarlimab in subjects with acute gouty arthristis.",[55],"Acute Gouty Arthritis","2026-04-02",{"date":58,"type":32},"2026-04-03",{"date":60,"type":32},"2026-03-26",{"date":62,"type":21},"2027-12-31",{"name":38,"class":39},1,""]