[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-gout-flare\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-gout-flare":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,67],{"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":25,"conditions":26,"keywords":34,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100489857","phase-2-study-of-dapansutrile-tablets-in-subjects-with-an-acute-gout-flare-100489857",false,"NCT05658575","Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare","A Multi-Center Phase 2\u002F3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare","Inclusion Criteria:\n\n* Male and female subjects age 18 or older\n* Clinical diagnosis of gout according to the 2015 ACR\u002FEULAR Gout Classification Criteria:\n\nA) Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by imaging evidence of urate deposition in the target joint or bursa at the Screening\u002FBaseline Visit\u002FStudy Day 1, or\n\nB) Documented history in the target joint or bursa ; or documented history of 2 or more gout flares in the previous 18 months\n\n* Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening\u002FBaseline Visit\n* Provide written informed consent and understand and comply with all trial requirements\n\nExclusion Criteria:\n\n* Presence of any palpable and visible tophi by physical examination\n* Has ≥ 4 joints with an acute gout flare at Screening\u002FBaseline\n* Presence of active rheumatoid arthritis or other acute inflammatory arthritis\n* Evidence\u002Fsuspicion of infectious\u002Fseptic arthritis\n* Clinically significant general pain or non-gout-related joint pain that would interfere with the subject's ability to accurately assess pain in the target joint\n* Known diagnosis of chronic kidney disease or known history of renal impairment\n* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening\u002FBaseline\n* Active malignancy or recent malignancy with any systemic anti-cancer treatment\n* Has a hypersensitivity or allergy to OLT1177® or other drugs in its class\n* Hypersensitivity or allergy to paracetamol\u002Facetaminophen\n* Use of any prohibited concomitant medications\u002Ftherapies over the periods defined in the protocol or planned use of any prohibited concomitant medications\u002Ftherapies during the Treatment Period (including the use of paracetamol\u002Facetaminophen within 4 hours prior to the Screening\u002FBaseline Visit or other pain medications within 12 hours prior to the Screening\u002F Baseline Visit\n* Use of any product containing paracetamol\u002Facetaminophen within 4 hours prior to the Screening\u002FBaseline Visit or planned use during the Treatment Period (with the exception of study-provided Rescue Medication \\[paracetamol\u002Facetaminophen\\], which is permitted after completion of the first target joint pain assessment on Study Day 4","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.",[27,28,29,30,31,32,33],"Acute Gout Flare","Gout Attack","Gout Flare","Gouty Arthritis","Gout","Arthritis","Joint Pain",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"gout","gouty arthritis","mono-articular arthritis","NLRP3","NLRP3 inhibitor","dapansutrile","OLT1177","joint pain","inflammation","gouty Inflammation","inflammasomes","IL-1 beta","IL-1 inflammation","autoinflammatory conditions","hyperuricemia","uric acid crystal","flare","small-molecule","therapeutic","RECRUITING","2026-03-09",{"date":57,"type":58},"2026-03-11","ACTUAL",{"date":60,"type":58},"2023-01-06",{"date":62,"type":20},"2027-01-31",{"name":64,"class":65},"Olatec Therapeutics LLC","INDUSTRY",40,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"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":76,"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.",[80,29,81,27],"Acute Gouty Arthritis","Gout Flares",[31,29,83,84,85],"Colchicine","Acute gout flare","ABP-745","2025-12-04",{"date":88,"type":58},"2025-12-08",{"date":90,"type":58},"2025-08-26",{"date":92,"type":20},"2026-06",{"name":94,"class":65},"Atom Therapeutics Co., Ltd",38]