Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT04052932
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2019-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Evaluating 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': '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 594}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with a serum uric level≤360μmol/l.', 'timeFrame': 'Week 12', 'description': 'Proportion of subjects with a serum uric level≤360μmol/l.'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with a serum uric level≤360μmol/l', 'timeFrame': 'Week 36', 'description': 'Proportion of subjects with a serum uric level≤360μmol/l'}, {'measure': 'Percentage change from baseline in serum uric level', 'timeFrame': 'Up to 36 weeks', 'description': 'Percentage change from baseline in serum uric level'}, {'measure': 'Actual change from baseline in serum uric level', 'timeFrame': 'Up to 36 weeks', 'description': 'Actual change from baseline in serum uric level'}, {'measure': 'Proportion of subjects with a serum uric level≤360μmol/l', 'timeFrame': 'Up to 36 weeks', 'description': 'Proportion of subjects with a serum uric level≤360μmol/l'}]}, 'oversightModule': {'oversightHasDmc': False, '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 placebo and Allopurinol in patients 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;\n2. 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 allopurinal, 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': 'NCT04052932', 'briefTitle': 'A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout', 'orgStudyIdInfo': {'id': 'SHR4640-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks', 'interventionNames': ['Drug: Placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'SHR4640 dose1', 'description': 'SHR4640 dose1 once a day, orally, for 36 weeks', 'interventionNames': ['Drug: SHR4640 dose1']}, {'type': 'EXPERIMENTAL', 'label': 'SHR4640 dose2', 'description': 'SHR4640 dose2 once a day, orally, for 36 weeks', 'interventionNames': ['Drug: SHR4640 dose2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol', 'description': 'Allopurinol 300mg (milligram) once a day, Orally, for 36 week', 'interventionNames': ['Drug: Allopurinol 300 MG']}], 'interventions': [{'name': 'SHR4640 dose1', 'type': 'DRUG', 'description': 'tablets，dose1，QD', 'armGroupLabels': ['SHR4640 dose1']}, {'name': 'SHR4640 dose2', 'type': 'DRUG', 'description': 'tablets，dose2，QD', 'armGroupLabels': ['SHR4640 dose2']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'tablets，QD', 'armGroupLabels': ['Placebo']}, {'name': 'Allopurinol 300 MG', 'type': 'DRUG', 'description': 'tablets，300mg，QD', 'armGroupLabels': ['Allopurinol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RenJi Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chunde Bao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}