Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT06439602
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2024-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D015210', 'term': 'Arthritis, Gouty'}, {'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': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6', 'timeFrame': '24 weeks', 'description': 'Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \\< 6 mg/dL at month 6'}], 'secondaryOutcomes': [{'measure': 'Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12', 'timeFrame': '12 weeks', 'description': 'Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \\< 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12'}, {'measure': 'No gout flares from the end of month 9 to the end of month 12', 'timeFrame': '12 weeks', 'description': 'Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12'}, {'measure': 'Change in tophus burden by month 12', 'timeFrame': '48 weeks', 'description': 'Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '56 weeks', 'description': 'Treatment Emergent Adverse Events and Serious Adverse Event incidence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout', 'Arthritis, Gouty', 'Hyperuricemia', 'Gout Chronic']}, 'descriptionModule': {'briefSummary': 'This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of gout\n* Occurrence of ≥ 2 self-reported gout flares in the last 12 months\n* Body weight no less than 50 kg\n* Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL\n* Patients who are on medically appropriate ULT must have sUA \\> 6 mg/dL\n* Serum creatinine must be \\< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min\n\nExclusion Criteria:\n\n* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin\n* Pregnant or breastfeeding\n* History of symptomatic kidney stones within the past 6 months'}, 'identificationModule': {'nctId': 'NCT06439602', 'briefTitle': 'Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)', 'organization': {'class': 'INDUSTRY', 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mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Solid Oral Capsule Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (106)', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (139)', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (160)', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85037', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (112)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 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