Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT04956432
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2021-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720748', 'term': 'ruzinurad'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 779}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with a serum uric acid level≤360 μmol/L', 'timeFrame': 'Start of Treatment to end of study (approximately 16 weeks)'}], 'secondaryOutcomes': [{'measure': 'Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 16 weeks)'}, {'measure': 'Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 16 weeks)'}, {'measure': 'The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 16 weeks)'}, {'measure': 'Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 52 weeks)'}, {'measure': 'change value of serum uric acid from baseline at each visit within 52 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 52 weeks)'}, {'measure': 'proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 52 weeks)'}, {'measure': 'serum uric acid value at each visit within 52 weeks of treatment', 'timeFrame': 'Start of Treatment to end of study (approximately 52 weeks)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.\n\nExclusion Criteria:\n\n1. Subject who is pregnant or breastfeeding;\n2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\\>1.5 upper normal limit;\n3. Subject with a positive test for HLA-B\\*5801;\n4. Estimated glomerular filtration rate (MDRD formula) \\<60ml/min;\n5. HbA1c≥8%;\n6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;\n7. Subject with kidney stones or suspicion of kidney stones;\n8. Subject who has acute gout flares within 2 weeks before randomization;\n9. Subject with a history of malignancy within the previous 5 years;\n10. Subject with a history of active peptic ulcer within a year;\n11. Subject with a history of xanthine urine.'}, 'identificationModule': {'nctId': 'NCT04956432', 'briefTitle': 'A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout', 'orgStudyIdInfo': {'id': 'SHR4640-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'description': 'SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks', 'interventionNames': ['Drug: SHR4640']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group B', 'description': 'Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.', 'interventionNames': ['Drug: Allopurinol']}], 'interventions': [{'name': 'SHR4640', 'type': 'DRUG', 'description': 'SHR4640 Dose 1 ,tablets, QD', 'armGroupLabels': ['Treatment group A']}, {'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Allopurinol 300mg, tablets, QD', 'armGroupLabels': ['Treatment group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RenJi Hospital, Shanghai JiaoTong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}