Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT05586958
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2022-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 354}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2025-10-23', 'completionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2022-10-16', 'studyFirstSubmitQcDate': '2022-10-16', 'dispFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6', 'timeFrame': 'Up to Month 6', 'description': 'Serum uric acid (sUA) level will be measured at Month 4,5, and 6'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6', 'timeFrame': 'Up to Month 6', 'description': 'Serum uric acid (sUA) level will be measured at Month 4,5, and 6'}, {'measure': 'The proportion of subjects reporting a gout flare up to each visit.', 'timeFrame': 'Up to Month 6', 'description': 'Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 6 months'}, {'measure': 'Incidence rate of adverse event', 'timeFrame': 'Up to Month 6', 'description': 'Safety assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gout', 'Hyperuricemia', 'Xanthine Oxidase Inhibitor'], 'conditions': ['Gout', 'Hyperuricemia', 'Gout Flare', 'Tophi']}, 'referencesModule': {'references': [{'pmid': '39929260', 'type': 'DERIVED', 'citation': 'Saag KG, Dalbeth N, Hsu CY, Kuo CF, Nuki G, Perez-Ruiz F, White WB, Hariri A, Lee Y, Jang Y, Han S, Choi HK. Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies. Contemp Clin Trials. 2025 Apr;151:107843. doi: 10.1016/j.cct.2025.107843. Epub 2025 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between the ages of 18 85 years, inclusive.\n* Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.\n* Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.\n* Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).\n\nExclusion Criteria:\n\n* Subjects with secondary hyperuricemia, enzymatic defects.\n* Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).\n* Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.\n* Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).\n* Subjects with a history of xanthinuria (elevated levels of xanthine in the urine) and rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT05586958', 'acronym': 'EURELIA1', 'briefTitle': 'Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia', 'orgStudyIdInfo': {'id': 'LG-GDCL009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tigulixostat 100mg', 'description': 'Tigulixostat 100mg, Once a day (QD) for up to 6 months', 'interventionNames': ['Drug: Tigulixostat']}, {'type': 'EXPERIMENTAL', 'label': 'Tigulixostat 200mg', 'description': 'Tigulixostat 200mg, Once a day (QD) for up to 6 months', 'interventionNames': ['Drug: Tigulixostat']}, {'type': 'EXPERIMENTAL', 'label': 'Tigulixostat 300mg', 'description': 'Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months', 'interventionNames': ['Drug: Tigulixostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, Once a day (QD) for up to 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tigulixostat', 'type': 'DRUG', 'otherNames': ['LC350189'], 'description': 'Xanthine Oxidase Inhibitor', 'armGroupLabels': ['Tigulixostat 100mg', 'Tigulixostat 200mg', 'Tigulixostat 300mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91722', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Medvin Clinical Research', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc.', 'geoPoint': {'lat': 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