Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT06501534
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects in each treatment group with serum uric acid levels <360 μmol/L after continuous treatment for 16 weeks', 'timeFrame': 'Week 16'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects in each treatment group with serum uric acid levels <300 μmol/L after continuous treatment for 16 weeks', 'timeFrame': 'Week 16'}, {'measure': 'The proportion of subjects in each treatment group with serum uric acid levels <360, <300 μmol/L after continuous treatment for 2, 4, 8, 12 weeks', 'timeFrame': 'Week 2, 4, 8, 12'}, {'measure': 'Absolute and percentage Changes in serum uric acid levels from baseline in subjects of each treatment group after continuous treatment for 2, 4, 8, 12, and 16 weeks', 'timeFrame': 'Baseline, Week 2, 4, 8, 12'}, {'measure': 'The proportion of subjects experiencing gout flares and the number of gout flare occurrences within every 4 weeks from the first dose, among those receiving various doses of Tigulixostat tablets and Febuxostat tablets', 'timeFrame': 'Baseline through Week 16/18'}, {'measure': 'Number of subjects with Adverse Event, Serious Adverse Events, Treatment Emergent Adverse Event, Adverse event of special interest', 'timeFrame': 'Baseline through Week 18/20'}, {'measure': 'Number of subjects with clinically significant changes in physical examination results', 'timeFrame': 'Baseline through Week 16/18', 'description': 'Clinically significant abnormal physical examination findings reported by the investigator.'}, {'measure': 'Number of subjects with clinically significant changes in in vital sign', 'timeFrame': 'Baseline through Week 16/18', 'description': 'Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure.'}, {'measure': 'Number of subjects with clinically significant changes in clinical laboratory parameters', 'timeFrame': 'Baseline through Week 16/18', 'description': 'Clinical laboratory parameters including white blood cell, red blood cell, hemoglobin, platelet, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, serum creatinine, fasting serum glucose, toal bilirubin, direct bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, serum potassium, creatine phosphokinase, hs-CRP, prothrombin time, thrombin time, activated partial thromboplastin time, international normalized ratio'}, {'measure': 'Number of subjects with clinically significant changes in electrodiagram', 'timeFrame': 'Baseline through Week 16/18', 'description': "Electrodiagram parameters including PRinterval, heart rate, RRinterval, corrected QT interval by Fridericia's formula"}, {'measure': 'Plasma concentration of Tigulixostat', 'timeFrame': 'Baseline through Week 16/18'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'IBI128 (Tigulixostat) is a novel non-purine selective inhibitor of xanthine oxidase (XO). The XO inhibitors lower uric acid concentrations in serum by inhibiting the production of uric acid.\n\nThis ia a randomized, open label, multicenter, parallel-group, positive-controlled, dose finding, and Phase II study to assess efficacy and safety of IBI128 in chinese gout subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Participants must be aged between 18 and 75 years old (inclusive, as of the time of signing the informed consent form), with no gender restrictions;\n2. Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);\n3. Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);\n4. At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;\n5. Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.\n\nExclusion criteria (brief):\n\n1. History of allergy to any component of Tigulixostat;\n2. Previous allergy or intolerance to Febuxostat;\n3. Subjects who have taken uric acid lowering medications within 2 weeks prior to screening;\n4. Subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration;\n5. Subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency);\n6. Subjects with a history of xanthinuria.'}, 'identificationModule': {'nctId': 'NCT06501534', 'briefTitle': 'A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Randomized, Open Label, Multicenter, Parallel-group, Positive-controlled, Dose Finding, and Phase II Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects', 'orgStudyIdInfo': {'id': 'CIBI128A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Febuxostat 40mg', 'description': 'Tablets, Once a day (QD), Per oral', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'EXPERIMENTAL', 'label': 'IBI128 50mg', 'description': 'Tablets, Once a day (QD), Per oral', 'interventionNames': ['Drug: IBI128']}, {'type': 'EXPERIMENTAL', 'label': 'IBI128 200mg', 'description': 'Tablets, Once a day (QD), Per oral', 'interventionNames': ['Drug: IBI128']}, {'type': 'EXPERIMENTAL', 'label': 'IBI128 100mg', 'description': 'Tablets, Once a day (QD), Per oral', 'interventionNames': ['Drug: IBI128']}], 'interventions': [{'name': 'Febuxostat', 'type': 'DRUG', 'description': 'Tablets, Once a day (QD), Per oral', 'armGroupLabels': ['Febuxostat 40mg']}, {'name': 'IBI128', 'type': 'DRUG', 'description': 'Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral', 'armGroupLabels': ['IBI128 100mg', 'IBI128 200mg', 'IBI128 50mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Fudan University HuaShan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}