[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07145229":3,"trial-entities:NCT07145229":391,"trial-summary:NCT07145229":394},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":52,"secondary_outcomes":57,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":94,"locations":97,"central_contacts":382,"overall_officials":388,"references":389,"see_also_links":390},"NCT07145229","ABP-745-201","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","RECRUITING","2026-06","2025-12","2025-12-08","2025-08-26","Atom Therapeutics Co., Ltd","INDUSTRY",false,"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.",null,[19,20,21,22],"Acute Gouty Arthritis","Gout Flare","Gout Flares","Acute Gout Flare",[24,20,25,26,27],"Gout","Colchicine","Acute gout flare","ABP-745","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},380,"ESTIMATED",[36,41,45,48],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","ABP-745 Dose A","ABP-745 Dose A + Colchicine placebo - tablets (PO)",[38],{"type":37,"name":42,"description":43,"armGroupLabels":44},"ABP-745 Dose B","ABP-745 Dose B + Colchicine placebo - tablets (PO)",[42],{"type":37,"name":25,"description":46,"armGroupLabels":47},"ABP-745 placebo + Colchicine - tablets (PO)",[25],{"type":37,"name":49,"description":50,"armGroupLabels":51},"Placebo","ABP-745 placebo + Colchicine placebo - tablets (PO)",[49],[53],{"measure":54,"description":55,"timeFrame":56},"Change in Visual Analog Scale (VAS) pain score of the target joint","Change from baseline in 0-100 mm VAS pain score of the target joint","24 hours post the first dose of study drug",[58,61],{"measure":59,"timeFrame":60},"Change and percentage change from baseline in VAS pain score of the target joint","2-8 days post the first dose of study drug",{"measure":62,"description":63,"timeFrame":64},"Incidence of treatment-emergent adverse events (Safety and Tolerability)","TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.","up to 14 days post the first dose of study drug","ALL","18 Years","70 Years",{"inclusion":69,"exclusion":77,"raw_text":93},[70,71,72,73,74,75,76],"Age 18-70 years old (inclusive), male or female.","Body mass index (BMI)18-40 kg\u002Fm2 (inclusive).","Medical history and current findings consistent with diagnosis of gouty arthritis.","Subjects must have experienced 2 or more gout flares within 12 months prior to screening.","Onset of an acute gout flare, within 6 months","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).","Subjects agree to maintain a stable lifestyle (such as diet and exercise) during the study period.",[78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"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.","Use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) prior to first dose dose of study drug, at the investigator's discretion.","Administration of colchicine or ABP-745 within 14 days prior to first dose of study drug.","Subjects took any investigational drug in any clinical study within 1 month prior to first dose of study drug and throughout the study period.","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.","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.","Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout).","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","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.","History of malignancy within 5 years prior to screening, excluding localized cancers such as basal cell carcinoma.","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.","Women of childbearing potential as defined by Appendix 2.","Experienced only no or mild gout-related pain prior to first dose of study drug.","Use of gout flare prophylaxis (e.g., colchicine, NSAIDs, prednisone\u002Fmethylprednisolone) at the time of randomization based on conversation with subject and self-reported.","Corona Virus Disease (COVID) vaccination in the 4 weeks prior to randomization.","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.",[95,96],"ADULT","OLDER_ADULT",[98,107,115,124,132,139,147,154,160,168,176,184,192,199,207,216,223,230,236,244,251,260,263,271,279,287,295,302,310,318,326,334,342,349,356,359,367,375],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"Onyx Clinical Research","Peoria","Arizona","61636","United States",{"lat":105,"lon":106},33.5806,-112.23738,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":103,"geoPoint":112},"Exinia Research","La Mesa","California","91942",{"lat":113,"lon":114},32.76783,-117.02308,{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":103,"geoPoint":121},"Evergreen Clinical Trial","NOT_YET_RECRUITING","Norcross","Georgia","30003",{"lat":122,"lon":123},33.94121,-84.21353,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":103,"geoPoint":129},"Bioluminux Clinical Research","Naperville","Illinois","60540",{"lat":130,"lon":131},41.78586,-88.14729,{"facility":108,"status":8,"city":133,"state":134,"zip":135,"country":103,"geoPoint":136},"Des Moines","Iowa","50308",{"lat":137,"lon":138},41.60054,-93.60911,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":103,"geoPoint":144},"Northshore Research Associates","Alexandria","Louisiana","71303",{"lat":145,"lon":146},31.31129,-92.44514,{"facility":148,"status":8,"city":149,"state":142,"zip":150,"country":103,"geoPoint":151},"DelRicht Research","Baton Rouge","70769",{"lat":152,"lon":153},30.44332,-91.18747,{"facility":148,"status":8,"city":155,"state":142,"zip":156,"country":103,"geoPoint":157},"New Orleans","70115",{"lat":158,"lon":159},29.95465,-90.07507,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":103,"geoPoint":165},"Interphase Clinical Trials","Lutherville","Maryland","21093",{"lat":166,"lon":167},39.42122,-76.62608,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":103,"geoPoint":173},"DelRicht Research Gulfport","Gulfport","Mississippi","39501",{"lat":174,"lon":175},30.36742,-89.09282,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":103,"geoPoint":181},"Albuquerque Clinical Trials, Inc.","Albuquerque","New Mexico","87176",{"lat":182,"lon":183},35.08449,-106.65114,{"facility":185,"status":117,"city":186,"state":187,"zip":188,"country":103,"geoPoint":189},"West Clinical Research","Morehead City","North Carolina","28557",{"lat":190,"lon":191},34.72294,-76.72604,{"facility":148,"status":8,"city":193,"state":194,"zip":195,"country":103,"geoPoint":196},"Tulsa","Oklahoma","74133",{"lat":197,"lon":198},36.15398,-95.99277,{"facility":200,"status":117,"city":201,"state":202,"zip":203,"country":103,"geoPoint":204},"Premier Family Physicians","Austin","Texas","78734",{"lat":205,"lon":206},30.26715,-97.74306,{"facility":208,"status":8,"city":209,"state":210,"zip":211,"country":212,"geoPoint":213},"Emeritus Sydney","Botany","New South Wales","2019","Australia",{"lat":214,"lon":215},-33.94599,151.19591,{"facility":217,"status":8,"city":218,"state":210,"zip":219,"country":212,"geoPoint":220},"Canopy Clinical Research Northern Beaches","Brookvale","2100",{"lat":221,"lon":222},-33.76108,151.27446,{"facility":224,"status":8,"city":225,"state":210,"zip":226,"country":212,"geoPoint":227},"Novatrials","Kotara","2289",{"lat":228,"lon":229},-32.94282,151.69585,{"facility":231,"status":8,"city":232,"state":210,"zip":211,"country":212,"geoPoint":233},"Genesis Research Services","Newcastle",{"lat":234,"lon":235},-32.92953,151.7801,{"facility":237,"status":8,"city":238,"state":239,"zip":240,"country":212,"geoPoint":241},"Emeritus Melbourne","Camberwell","Victoria","3124",{"lat":242,"lon":243},-37.84205,145.0694,{"facility":245,"status":8,"city":246,"state":239,"zip":247,"country":212,"geoPoint":248},"Canopy Clinical Research Altona North","North Altona","3025",{"lat":249,"lon":250},-37.83487,144.84735,{"facility":252,"status":8,"city":253,"state":254,"zip":255,"country":256,"geoPoint":257},"Peking University Third hospital","Beijing","Beijing Municipality","100000","China",{"lat":258,"lon":259},39.9075,116.39723,{"facility":261,"status":8,"city":253,"state":254,"zip":255,"country":256,"geoPoint":262},"Xuanwu Hospital Capital Medical University",{"lat":258,"lon":259},{"facility":264,"status":8,"city":265,"state":266,"zip":267,"country":256,"geoPoint":268},"The second affiliated hospital of guangxi medical university","Nanning","Guangxi","530000",{"lat":269,"lon":270},22.81667,108.31667,{"facility":272,"status":8,"city":273,"state":274,"zip":275,"country":256,"geoPoint":276},"Hebei Petro China Central Hospital","Langfang","Hebei","065000",{"lat":277,"lon":278},39.52079,116.71471,{"facility":280,"status":8,"city":281,"state":282,"zip":283,"country":256,"geoPoint":284},"Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430000",{"lat":285,"lon":286},30.58333,114.26667,{"facility":288,"status":8,"city":289,"state":290,"zip":291,"country":256,"geoPoint":292},"Xiangtan Central Hospital","Xiangtan","Hunan","411100",{"lat":293,"lon":294},27.85,112.9,{"facility":296,"status":8,"city":297,"state":290,"zip":298,"country":256,"geoPoint":299},"Xiangya Hospital Zhuzhou Central South University","Zhuzhou","412000",{"lat":300,"lon":301},27.83333,113.15,{"facility":303,"status":8,"city":304,"state":305,"zip":306,"country":256,"geoPoint":307},"Huai'an First People's Hospital","Huai'an","Jiangsu","223000",{"lat":308,"lon":309},33.58861,119.01917,{"facility":311,"status":8,"city":312,"state":313,"zip":314,"country":256,"geoPoint":315},"Pingxiang People's Hospital","Pingxiang","Jiangxi","337000",{"lat":316,"lon":317},27.61672,113.85353,{"facility":319,"status":8,"city":320,"state":321,"zip":322,"country":256,"geoPoint":323},"Zaozhuang Municipal Hospital","Zaozhuang","Shandong","277100",{"lat":324,"lon":325},34.86472,117.55417,{"facility":327,"status":8,"city":328,"state":329,"zip":330,"country":256,"geoPoint":331},"Huashan Hospital, Fudan University","Shanghai","Shanghai Municipality","200040",{"lat":332,"lon":333},31.22222,121.45806,{"facility":335,"status":8,"city":336,"state":337,"zip":338,"country":256,"geoPoint":339},"Linfen Central hospital","Linfen","Shanxi","041000",{"lat":340,"lon":341},36.08889,111.51889,{"facility":343,"status":8,"city":344,"state":337,"zip":345,"country":256,"geoPoint":346},"Shanxi Bethune Hospital","Taiyuan","030000",{"lat":347,"lon":348},37.86944,112.56028,{"facility":350,"status":8,"city":351,"state":337,"zip":352,"country":256,"geoPoint":353},"Shaanxi Provincial People's Hospital","Xi’an","710000",{"lat":354,"lon":355},35.99785,113.52486,{"facility":357,"status":8,"city":351,"state":337,"zip":352,"country":256,"geoPoint":358},"Xi'an Daxing Hospital",{"lat":354,"lon":355},{"facility":360,"status":8,"city":361,"state":362,"zip":363,"country":256,"geoPoint":364},"Chengdu Fifth People's Hospital","Chengdu","Sichuan","610000",{"lat":365,"lon":366},30.66667,104.06667,{"facility":368,"status":8,"city":369,"state":370,"zip":371,"country":256,"geoPoint":372},"Hangzhou First People's Hospital","Hangzhou","Zhejiang","310000",{"lat":373,"lon":374},30.29365,120.16142,{"facility":376,"status":8,"city":377,"state":370,"zip":378,"country":256,"geoPoint":379},"Wenzhou People's Hospital","Wenzhou","325000",{"lat":380,"lon":381},27.99942,120.66682,[383],{"name":384,"role":385,"phone":386,"email":387},"Ullrich Schwertschlag, MD,PhD","CONTACT","1-978-257-1926","ullrich.schwertschlag@atombp.com",[],[],[],{"nct_id":4,"conditions":392,"biomarkers":393},[24],[],{"nct_id":4,"found":395,"summary":396,"prompt_version":406},true,{"design":397,"status":398,"heading":399,"summary":400,"follow_up":401,"word_count":402,"commitments":403,"compensation":404,"drugs_mentioned":405},"This is a randomized, double-blind study involving 380 participants across multiple international locations. Participants will receive either ABP-745 (at one of two doses), colchicine, or a placebo.","completed","Study of ABP-745 for Acute Gout Flares","This study is testing a new drug called ABP-745 to see if it can help reduce pain and swelling during an acute gout flare (a sudden, severe attack of gout). Researchers want to compare ABP-745 to standard colchicine treatment and a placebo (an inactive substance). You might be able to join if you are 18 to 70 years old, have a body mass index (BMI) between 18 and 40, and have had at least two gout flares in the past year. The main goal is to see how much your pain improves after 24 hours of taking the study drug.","The primary endpoint measures pain at 24 hours after the first dose of the study drug.",100,"Not specified in the trial record.","Not stated in the trial record.",[25,49],"v2"]