[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Crystalys Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100634080","phase-2-a-phase-2-trial-of-dotinurad-in-xanthine-oxidase-inhibitor-xoi-intoleranturicase-failure-gout-participants-100634080",false,"NCT07535034","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","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.","ALL","18 Years","75 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27],"Gout",[29,30],"Dotinurad","Xanthine Oxidase Inhibitors","RECRUITING","2026-06-08",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2026-05-08",{"date":39,"type":21},"2027-08",{"name":41,"class":42},"Crystalys Therapeutics","INDUSTRY",17,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100599852","phase-3-a-study-of-dotinurad-versus-allopurinol-in-participants-with-gout-100599852","NCT07089875","A Study of Dotinurad Versus Allopurinol in Participants With Gout","A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout","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.\n3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).\n4. Participant must be on a stable background allopurinol dose of ≥300 mg\u002Fday (200 mg\u002Fday for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg\u002Fday for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.\n5. sUA level ≥6.5 mg\u002FdL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).\n6. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.\n7. 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 study 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. Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.\n4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.\n5. Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.\n6. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.",{"count":52,"type":21},500,[54],"PHASE3","The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.",[27],[29,58,59],"Allopurinol","Hyperuricemia","2026-06-04",{"date":32,"type":35},{"date":63,"type":35},"2025-08-01",{"date":65,"type":21},"2027-11-29",{"name":41,"class":42},100,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100599853","phase-3-a-study-of-dotinurad-versus-allopurinol-in-tophaceous-gout-100599853","NCT07089888","A Study of Dotinurad Versus Allopurinol in Tophaceous Gout","A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout","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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.\n3. Has ≥1 measurable tophus on the hands\u002Fwrists and\u002For feet\u002Fankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.\n4. sUA level ≥5.0 mg\u002FdL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).\n5. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.\n6. 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 study 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. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).\n4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.\n5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.",{"count":76,"type":21},250,[54],"The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.",[80],"Tophaceous Gout",[80,29,58,59],"2026-05-19",{"date":84,"type":35},"2026-05-20",{"date":86,"type":35},"2025-08-04",{"date":88,"type":21},"2027-12-31",{"name":41,"class":42},86,""]