[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gout-flares\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gout-flares":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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"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},"100638303","efficacy-and-safety-of-scheduled-versus-as-needed-firsekibart-administration-for-the-prevention-of-gout-recurrence-a-multicenter-open-label-randomized-controlled-trial-100638303",false,"NCT07616531","Efficacy and Safety of Scheduled Versus As-Needed Firsekibart Administration for the Prevention of Gout Recurrence: A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive), male or female;\\*\\*\n2. Meet the 2015 ACR\u002FEULAR Gout Classification Criteria;\\*\\*\n3. Received initial treatment with Firsekibart 200 mg via subcutaneous injection for 24 weeks, and experienced no gout flares during this 24-week period;\\*\\*\n4. Had≥2 gout flares within 1 year prior to the first administration of Firsekibart；\n5. Willing to comply with the protocol-defined urate-lowering therapy (ULT) during the study, meeting one of the following conditions:\n\n   * Patients currently receiving ULT with a stable regimen for≥14 days may continue their stable dosing; adjustments (including medication switch, dose reduction, or discontinuation) are permitted if the investigator assesses intolerance, poor efficacy, or achievement of target serum uric acid levels;\n\n     * For patients not on ULT or those on ULT but not stable for 14 days before enrollment, the investigator will decide whether to initiate ULT based on uric acid levels. In principle, allopurinol-naive patients should not be prescribed allopurinol in this study;\n6. Voluntarily signed the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. History of hypersensitivity to the study drug or similar classes of drugs;\n2. Systemic treatment with corticosteroids, or use of colchicine\u002FNSAIDs within 24 weeks prior to enrollment;\n3. Confirmed active visceral bleeding, or severe bleeding tendency, or currently receiving anticoagulation therapy with heparin;\n4. Confirmed secondary gout;\n5. Confirmed or suspected rheumatoid arthritis, infectious\u002Fseptic arthritis, or other conditions that may confound the assessment of affected joints (e.g., other joint pain including but not limited to neurological disorders, herpes zoster, etc.);\n6. Presence of infection requiring systemic treatment within 7 days prior to screening;\n7. Received live or live-attenuated vaccines within 3 months prior to screening, or planned vaccination with such vaccines during the study;\n8. History of malignancy within 5 years prior to screening, except for adequately treated or excised cutaneous basal cell carcinoma or Stage I squamous cell carcinoma;\n9. History of systemic irradiation or total lymphoid irradiation; history of stem cell therapy or any type of bone marrow transplantation; history of solid organ transplantation; or long-term systemic use of immunosuppressants;\n10. History of severe immunodeficiency, including positive human immunodeficiency virus (HIV) antibody, or other acquired or congenital immunodeficiency diseases;\n11. History of clinically significant diseases, including:\n\n    Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) \\\u003C 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs; History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG ;\n12. Confirmed active tuberculosis infection;\n13. Receiving renal dialysis;\n14. Laboratory abnormalities at screening as follows:\n\n    White blood cellcount or absolute neutrophil count below the lower limit of normal at the study site; Platelet count ≤100×10\\^9\u002FL; Total bilirubin \\> 1.5 times ULN (Upper Limit of Normal); AST\u002FALT \\> 3 times ULN; Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m²; Triglycerides \\> 5.7 mmol\u002FL;\n15. Pregnant or breastfeeding women;\n16. Women of childbearing potential who refuse to use highly effective contraception during the study;\n17. Use of any investigational drug or participation in other interventional clinical trials within 1 month prior to screening (participation in observational studies only is permitted);\n18. History of drug and\u002For alcohol abuse or psychiatric disorders;\n19. Any other conditions that, in the opinion of the investigator, may affect the evaluation of efficacy or safety in this study.","ALL","18 Years","75 Years",{"count":19,"type":20},118,"ESTIMATED","INTERVENTIONAL",[23],"NA","Study Objective To compare the efficacy of continued scheduled dosing versus as-needed dosing in patients with acute gouty arthritis who remained recurrence-free after 24 weeks of treatment with Firsekibart.\n\nPrimary Endpoint The proportion of patients experiencing at least one gout recurrence within 24 weeks after randomization.\n\nSecondary Endpoints The mean number of gout recurrences within 24 weeks after randomization;The duration of the first gout recurrence;The proportion of patients experiencing at least one gout recurrence within 12 weeks after randomization;Time to first gout recurrence after randomization;Patient treatment satisfaction at 24 weeks after randomization, assessed using a Likert scale.\n\nStudy Design and Methods Patients with acute gouty arthritis who had received Firsekibart as initial treatment and experienced no recurrence during the first 24 weeks of treatment were eligible for enrollment and randomization in this study. Eligible patients were randomized to either a scheduled dosing group or an as-needed dosing group.\n\nIn the scheduled dosing group, patients received study treatment immediately after enrollment. In the as-needed dosing group, patients entered an observation period after enrollment and received study treatment only in the event of recurrence.\n\nDuring the study, gout recurrence was recorded using patient diary cards. Telephone follow-up was conducted every 4 weeks to confirm recurrence status. On-site visits were performed at Weeks 12 and 24, as well as at the time of gout recurrence, for collection of efficacy-related assessments. Adverse events (AEs) and serious adverse events (SAEs) were followed until 12 weeks after the last dose of study drug.\n\nTreatment Arms Scheduled Dosing Group (Intervention Group): Firsekibart 200 mg was administered by subcutaneous injection on the day of randomization.\n\nAs-Needed Dosing Group (Control Group): Patients were observed after randomization. If recurrence occurred, patients were required to return to the hospital within 4 days and receive Firsekibart 200 mg by subcutaneous injection.",[26],"Gout Flares","NOT_YET_RECRUITING","2026-05-24",{"date":30,"type":31},"2026-06-01","ACTUAL",{"date":33,"type":20},"2026-05-01",{"date":35,"type":20},"2030-02-28",{"name":37,"class":38},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",11,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"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,[51],"PHASE2","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.",[54,55,26,56],"Acute Gouty Arthritis","Gout Flare","Acute Gout Flare",[58,55,59,60,61],"Gout","Colchicine","Acute gout flare","ABP-745","RECRUITING","2025-12-04",{"date":65,"type":31},"2025-12-08",{"date":67,"type":31},"2025-08-26",{"date":69,"type":20},"2026-06",{"name":71,"class":72},"Atom Therapeutics Co., Ltd","INDUSTRY",38]