[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07535034":3,"trial-entities:NCT07535034":394,"trial-summary:NCT07535034":398},{"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":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":45,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":77,"locations":80,"central_contacts":381,"overall_officials":386,"references":387,"see_also_links":388},"NCT07535034","FYU-981-CRYS-201","A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant\u002FUricase Failure Gout Participants","A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment","RECRUITING","2027-08","2026-07","2026-07-30","2026-05-08","Crystalys Therapeutics","INDUSTRY",true,"The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.",null,[19],"Gout",[21,22],"Dotinurad","Xanthine Oxidase Inhibitors","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},90,"ESTIMATED",[31,36],{"type":32,"name":21,"description":33,"armGroupLabels":34},"DRUG","Over-encapsulated tablets containing active drug substance administered orally.",[21,35],"Placebo + Placebo to Dotinuard",{"type":37,"name":38,"description":39,"armGroupLabels":40},"OTHER","Placebo","Capsules containing microcrystalline cellulose administered orally.",[35],[42],{"measure":43,"timeFrame":44},"Percentage of Participants With an sUA Level \u003C6.0 mg\u002FdL at Week 24","Week 24",[46,49,52,55,58,60,64],{"measure":47,"timeFrame":48},"Percentage of Participants With an sUA Level \u003C6.0 mg\u002FdL at Weeks 16, 20 and 24","Weeks 16, 20 and 24",{"measure":50,"timeFrame":51},"Percentage of Participants With an sUA Level \u003C6.0 \u003C5.0, \u003C4.0, and \u003C3.0 mg\u002FdL at Each Visit","Up to Week 40",{"measure":53,"timeFrame":54},"Mean Change From Baseline in sUA at Week 24","Baseline and Week 24",{"measure":56,"timeFrame":57},"Absolute Change from Baseline in sUA Levels at Each Visit","Baseline to Week 40",{"measure":59,"timeFrame":57},"Percent Change from Baseline in sUA Levels at Each Visit",{"measure":61,"description":62,"timeFrame":63},"Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Treatment Periods 1 and 2","Any clinically significant changes from baseline in safety laboratory values and vital signs will be reported as AEs per investigators discretion.","Screening to Week 36",{"measure":65,"description":62,"timeFrame":66},"Number of Participants With TEAEs and SAEs Throughout the Study","Screening to Week 40","ALL","18 Years","75 Years",false,{"inclusion":72,"exclusion":75,"raw_text":76},[73,74],"History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.","Failed uricase treatment (eg, an sUA level \\>6.0 mg\u002FdL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment). 3. sUA level \\>6.0 and \\\u003C10.5 mg\u002FdL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit). 4. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding. 5. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of trial drug.",[],"Inclusion Criteria:\n\n1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.\n2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:\n\n   * History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.\n   * Failed uricase treatment (eg, an sUA level \\>6.0 mg\u002FdL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).\n3. sUA level \\>6.0 and \\\u003C10.5 mg\u002FdL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).\n4. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.\n5. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of trial drug.\n\nExclusion Criteria:\n\n1. History of or presence of kidney stones within 1 year prior to Screening.\n2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.\n3. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.\n4. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.\n5. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.",[78,79],"ADULT","OLDER_ADULT",[81,94,104,114,125,136,146,156,166,176,186,196,203,214,225,235,246,257,268,278,289,300,311,321,331,341,351,361,371],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":91},"Amicis Research Center","Granada Hills","California","91344","United States",[88],{"name":89,"role":90},"Pascal Dabel, MD","CONTACT",{"lat":92,"lon":93},34.26472,-118.52314,{"facility":95,"status":8,"city":96,"state":84,"zip":97,"country":86,"contacts":98,"geoPoint":101},"Cohen Medical Center","Thousand Oaks","91360",[99],{"name":100,"role":90},"Shariar Cohen-Gadol, MD",{"lat":102,"lon":103},34.17056,-118.83759,{"facility":105,"status":8,"city":106,"state":84,"zip":107,"country":86,"contacts":108,"geoPoint":111},"Solace Clinical Research","Tustin","92780",[109],{"name":110,"role":90},"Roger Kornu, MD",{"lat":112,"lon":113},33.74585,-117.82617,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":86,"contacts":119,"geoPoint":122},"Denver Arthritis Clinic - Lowry","Denver","Colorado","80230",[120],{"name":121,"role":90},"Christopher Antolini, MD",{"lat":123,"lon":124},39.73915,-104.9847,{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":86,"contacts":130,"geoPoint":133},"Omega Research Group","DeBary","Florida","32713",[131],{"name":132,"role":90},"Kwabena Ayesu, MD",{"lat":134,"lon":135},28.88305,-81.30868,{"facility":137,"status":8,"city":138,"state":128,"zip":139,"country":86,"contacts":140,"geoPoint":143},"Herco Medical and Research Center, Inc","Flagami","33126",[141],{"name":142,"role":90},"Eddy Capote, MD",{"lat":144,"lon":145},25.76232,-80.31616,{"facility":147,"status":8,"city":148,"state":128,"zip":149,"country":86,"contacts":150,"geoPoint":153},"New Generation of Medical Research","Hialeah","33016",[151],{"name":152,"role":90},"Karelia Ruiz, MD",{"lat":154,"lon":155},25.8576,-80.27811,{"facility":157,"status":8,"city":158,"state":128,"zip":159,"country":86,"contacts":160,"geoPoint":163},"Health Awareness, Inc.","Jupiter","33458",[161],{"name":162,"role":90},"Ronald Surowitz, MD",{"lat":164,"lon":165},26.93422,-80.09421,{"facility":167,"status":8,"city":168,"state":128,"zip":169,"country":86,"contacts":170,"geoPoint":173},"Clinical Research of Central Florida","Lakeland","33805",[171],{"name":172,"role":90},"Michael Gimness, MD",{"lat":174,"lon":175},28.03947,-81.9498,{"facility":177,"status":8,"city":178,"state":128,"zip":179,"country":86,"contacts":180,"geoPoint":183},"D&H Pompano Research Center, LLC","Margate","33063",[181],{"name":182,"role":90},"Mazyar Rouhani, MD",{"lat":184,"lon":185},26.24453,-80.20644,{"facility":187,"status":8,"city":188,"state":128,"zip":189,"country":86,"contacts":190,"geoPoint":193},"Panax Clinical Research","Miami","33014",[191],{"name":192,"role":90},"Robert Perry, MD",{"lat":194,"lon":195},25.77427,-80.19366,{"facility":197,"status":8,"city":188,"state":128,"zip":198,"country":86,"contacts":199,"geoPoint":202},"Anchor Medical Research","33176",[200],{"name":201,"role":90},"Juvenal Martinez, MD",{"lat":194,"lon":195},{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":86,"contacts":208,"geoPoint":211},"MD Medical Research","Oxon Hill","Maryland","20745",[209],{"name":210,"role":90},"Stephen Ong, MD",{"lat":212,"lon":213},38.80345,-76.9897,{"facility":215,"status":8,"city":216,"state":217,"zip":218,"country":86,"contacts":219,"geoPoint":222},"Clinical Research Institute of Michigan","Saint Clair Shores","Michigan","48081",[220],{"name":221,"role":90},"Amar Majjhoo, MD",{"lat":223,"lon":224},42.49698,-82.88881,{"facility":226,"status":8,"city":227,"state":217,"zip":228,"country":86,"contacts":229,"geoPoint":232},"Revival Research Institute","Sterling Heights","48313",[230],{"name":231,"role":90},"Syed Husain, MD",{"lat":233,"lon":234},42.58031,-83.0302,{"facility":236,"status":8,"city":237,"state":238,"zip":239,"country":86,"contacts":240,"geoPoint":243},"Las Vegas Clinical Trials","Las Vegas","Nevada","89030",[241],{"name":242,"role":90},"Alton Walters, MD",{"lat":244,"lon":245},36.17497,-115.13722,{"facility":247,"status":8,"city":248,"state":249,"zip":250,"country":86,"contacts":251,"geoPoint":254},"Premier Health Research","Sparta","New Jersey","07871",[252],{"name":253,"role":90},"Haroon Sarwar, MD",{"lat":255,"lon":256},41.03343,-74.63849,{"facility":258,"status":8,"city":259,"state":260,"zip":261,"country":86,"contacts":262,"geoPoint":265},"Ellipsis Research Group","Brooklyn","New York","11215",[263],{"name":264,"role":90},"Jorge Serje, MD",{"lat":266,"lon":267},40.6501,-73.94958,{"facility":269,"status":8,"city":270,"state":260,"zip":271,"country":86,"contacts":272,"geoPoint":275},"Drug Trials America","Hartsdale","10530",[273],{"name":274,"role":90},"Michael Gerdis, MD",{"lat":276,"lon":277},41.01899,-73.79819,{"facility":279,"status":8,"city":280,"state":281,"zip":282,"country":86,"contacts":283,"geoPoint":286},"Shelby Clinical Research","Shelby","North Carolina","28150",[284],{"name":285,"role":90},"Christian Martin, MD",{"lat":287,"lon":288},35.29235,-81.53565,{"facility":290,"status":8,"city":291,"state":292,"zip":293,"country":86,"contacts":294,"geoPoint":297},"Hometown Urgent Care and Research","Dayton","Ohio","45424",[295],{"name":296,"role":90},"Carol Bland, MD",{"lat":298,"lon":299},39.75895,-84.19161,{"facility":301,"status":8,"city":302,"state":303,"zip":304,"country":86,"contacts":305,"geoPoint":308},"Zenos Clinical Research","Dallas","Texas","75230",[306],{"name":307,"role":90},"Bachar Elsaadi, MD",{"lat":309,"lon":310},32.78306,-96.80667,{"facility":312,"status":8,"city":313,"state":303,"zip":314,"country":86,"contacts":315,"geoPoint":318},"Epic Medical Research","DeSoto","75115",[316],{"name":317,"role":90},"Haresh Boghara, MD",{"lat":319,"lon":320},32.58986,-96.85695,{"facility":322,"status":8,"city":323,"state":303,"zip":324,"country":86,"contacts":325,"geoPoint":328},"Pioneer Research Solutions","Houston","77479",[326],{"name":327,"role":90},"Francisco Velazquez, MD",{"lat":329,"lon":330},29.76328,-95.36327,{"facility":332,"status":8,"city":333,"state":303,"zip":334,"country":86,"contacts":335,"geoPoint":338},"R&H Clinical Research - Westborough Drive","Katy","77449",[336],{"name":337,"role":90},"Maryam Khawari, MD",{"lat":339,"lon":340},29.78579,-95.8244,{"facility":342,"status":8,"city":343,"state":303,"zip":344,"country":86,"contacts":345,"geoPoint":348},"Southwest Rheumatology Research","Mesquite","75150",[346],{"name":347,"role":90},"Atul Singhal, MD",{"lat":349,"lon":350},32.7668,-96.59916,{"facility":352,"status":8,"city":353,"state":303,"zip":354,"country":86,"contacts":355,"geoPoint":358},"Discovery Clinical Trials, LLC","San Antonio","78229",[356],{"name":357,"role":90},"Abha Gyani, MD",{"lat":359,"lon":360},29.42412,-98.49363,{"facility":362,"status":8,"city":363,"state":303,"zip":364,"country":86,"contacts":365,"geoPoint":368},"DM Clinical Research","Tomball","77375",[366],{"name":367,"role":90},"Shaikh Ali, MD",{"lat":369,"lon":370},30.09716,-95.61605,{"facility":372,"status":8,"city":373,"state":303,"zip":374,"country":86,"contacts":375,"geoPoint":378},"Digestive Health Research of North Texas","Wichita Falls","76301",[376],{"name":377,"role":90},"Vanya Wagler, MD",{"lat":379,"lon":380},33.91371,-98.49339,[382],{"name":383,"role":90,"phone":384,"email":385},"Clinical Trial Lead","1-858-379-2316","ClinicalTrials@crystalystx.com",[],[],[389,392],{"label":390,"url":391},"Related Info","http:\u002F\u002Fwww.crystalystx.com",{"label":390,"url":393},"http:\u002F\u002Fwww.jewelprogram.com",{"nct_id":4,"conditions":395,"biomarkers":396},[19],[397],"Uric Acid",{"nct_id":4,"found":15,"summary":399,"prompt_version":409},{"design":400,"status":401,"heading":402,"summary":403,"follow_up":404,"word_count":405,"commitments":406,"compensation":407,"drugs_mentioned":408},"This is an interventional study that will compare Dotinurad to a placebo. It plans to enroll 90 participants.","completed","Dotinurad for Gout in XOI Intolerant\u002FUricase Failure Participants","This study is testing a drug called Dotinurad to see how well it lowers high uric acid levels in people with gout. You might be able to join if you are between 18 and 75 years old, have had gout for at least a year, and can't take other common gout medicines (Xanthine Oxidase Inhibitors, or XOI) or if those medicines haven't worked for you (uricase treatment failure). The study will compare Dotinurad to a placebo (an inactive pill) to see what percentage of participants achieve a serum uric acid (sUA) level below 6.0 mg\u002FdL after 24 weeks. The study plans to enroll 90 participants, but the current recruitment status is unclear.","The primary goal is measured at Week 24, indicating follow-up for at least that long.",112,"Not specified in the trial record.","Not stated in the trial record.",[21,38],"v2"]