[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-gouty-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-gouty-arthritis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100627774","phase-2-a-study-to-evaluate-the-efficacysafetytolerabilitypharmacokineticsand-immunogenicty-of-plonmarlimab-in-subjects-with-acute-gouty-arthritis-100627774",false,"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.","ALL","18 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Acute Gouty Arthritis","RECRUITING","2026-04-02",{"date":30,"type":31},"2026-04-03","ACTUAL",{"date":33,"type":31},"2026-03-26",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"TJ Biopharma Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100604108","phase-2-safety-and-efficacy-of-abp-745-in-participants-with-an-acute-gout-flare-100604108","NCT07145229","Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare","A Randomized, Double-blind, Multicenter, Colchicine and Placebo-controlled Study to Evaluate the Efficacy and Safety of ABP-745 in Subjects With an Acute Gout Flare","Key Inclusion Criteria:\n\nSubjects are eligible for the study if they meet all of the following Inclusion Criteria:\n\n* Age 18-70 years old (inclusive), male or female.\n* Body mass index (BMI)18-40 kg\u002Fm2 (inclusive).\n* Medical history and current findings consistent with diagnosis of gouty arthritis.\n* Subjects must have experienced 2 or more gout flares within 12 months prior to screening.\n* Onset of an acute gout flare, within 6 months\n* Patients receiving ULT agents (such as allopurinol, febuxostat, probenecid, etc.) must be on stable doses of these drugs prior to first dose of study drug (and remain on the same dose throughout the Treatment Period).\n* Subjects agree to maintain a stable lifestyle (such as diet and exercise) during the study period.\n\nKey Exclusion Criteria:\n\nSubjects are excluded from the study if one or more of the following criteria are met:\n\n* Administration of oral prednisone ≥ 10 mg or equivalent doses of other glucocorticoids, or use of narcotics, within 24 hours prior to first dose of study drug, or intramuscular, intravenous, or intra-articular injection of any glucocorticoid within 14 days prior to first dose of study drug.\n* Use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) prior to first dose dose of study drug, at the investigator's discretion.\n* Administration of colchicine or ABP-745 within 14 days prior to first dose of study drug.\n* Subjects took any investigational drug in any clinical study within 1 month prior to first dose of study drug and throughout the study period.\n* Administration of pegloticase, or methotrexate, or any biologic IL-1 blocker, TNF inhibitor, or other biological agent within 30 days prior to first dose of study drug or within 5 half-lives of the study drug prior to the first dose of study drug, whichever is longer.\n* Administration of muscle relaxants, central stimulants, barbiturates, etc. within 30 days prior to first dose of study drug or within 5 half-lives of the drug prior to the first dose of study drug, whichever is longer.\n* Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout).\n* Subjects with a current diagnosis or history of rheumatoid arthritis, psoriatic arthritis, evidence or suspicion of infectious\u002Fseptic arthritis, calcium pyrophosphate (CPP) crystal arthritis, acute polyarticular gout (4 or more joints), multiple sclerosis or any other demyelinating disease, or; major chronic inflammatory disease or connective tissue disease other than RA or psoriatic arthritis (PsA), including but not limited to fibromyalgia or systemic lupus erythematosus (with the exception of secondary Sjögrens syndrome, etc.); with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion or Prosthetic joint infection within 5 years of screening, or native joint infection within 1 year of screening\n* Current anticoagulation therapy, thrombocytopenia, or diseases with a risk of thrombocytopenia, such as aplastic anemia, hypersplenism, or known hemorrhagic diseases like idiopathic thrombocytopenic purpura or hemophilia.\n* History of malignancy within 5 years prior to screening, excluding localized cancers such as basal cell carcinoma.\n* Presence of significant diseases, including but not limited to: uncontrolled hypertension (systolic blood pressure ≥160 or diastolic blood pressure ≥100 mmHg), congestive heart failure (New York Heart Association \\[NYHA\\] class III or above), uncontrolled type 1 or 2 diabetes mellitus (hemoglobin A1c \\[HbA1c\\] \\>8.5%). Inclusion will be determined by the Investigator based on the subject's specific condition.\n* Women of childbearing potential as defined by Appendix 2.\n* Experienced only no or mild gout-related pain prior to first dose of study drug.\n* Use of gout flare prophylaxis (e.g., colchicine, NSAIDs, prednisone\u002Fmethylprednisolone) at the time of randomization based on conversation with subject and self-reported.\n* Corona Virus Disease (COVID) vaccination in the 4 weeks prior to randomization.","70 Years",{"count":49,"type":20},380,[23],"A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ABP-745 in subjects with acute gout. Efficacy of ABP-745 in reducing pain and swelling compared with standard colchicine treatment and placebo will be evaluated in participants with acute gout. The primary efficacy measurement will be pain score after treatment.",[26,53,54,55],"Gout Flare","Gout Flares","Acute Gout Flare",[57,53,58,59,60],"Gout","Colchicine","Acute gout flare","ABP-745","2025-12-04",{"date":63,"type":31},"2025-12-08",{"date":65,"type":31},"2025-08-26",{"date":67,"type":20},"2026-06",{"name":69,"class":38},"Atom Therapeutics Co., Ltd",38]