Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 5:53 AM
Study NCT ID:
NCT05253833
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2022-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2024-11-22', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-02-15', 'dispFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3', 'timeFrame': '12 weeks', 'description': 'Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \\< 5 mg/dL at month 3'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in tophus area at Months 3 and 6', 'timeFrame': '12 weeks and 24 weeks', 'description': 'Comparison of the treatment groups for tophus area as measured by digital calipers'}, {'measure': 'Change from baseline in tophus crystal volume at Months 6', 'timeFrame': '24 weeks', 'description': 'Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.'}, {'measure': 'Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3', 'timeFrame': '12 weeks', 'description': 'Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \\<6, \\<4 and \\<3 mg/dL at month 3'}, {'measure': 'Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 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, \\< 5, \\<4 and \\<3 mg/dL at month 6'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '24 weeks', 'description': 'Treatment Emergent Adverse Events and Serious Adverse Event incidence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout', 'Arthritis, Gouty', 'Hyperuricemia', 'Gout Chronic']}, 'descriptionModule': {'briefSummary': 'This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of gout\n* at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.\n* Patients who are NOT on approved ULT must have sUA \\> 7 mg/dL\n* Patients who are on medically appropriate ULT must have sUA \\> 6 mg/dL\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2\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 kidney stones'}, 'identificationModule': {'nctId': 'NCT05253833', 'briefTitle': 'Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthrosi Therapeutics'}, 'officialTitle': 'A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients', 'orgStudyIdInfo': {'id': 'AR882-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Allopurinol once daily for 24 weeks', 'interventionNames': ['Drug: Allopurinol Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks', 'interventionNames': ['Drug: AR882 Dose 1', 'Drug: AR882 Dose 2']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'AR882 Dose 1 + Allopurinol for 24 weeks', 'interventionNames': ['Drug: AR882 Dose 1', 'Drug: Allopurinol Tablet']}], 'interventions': [{'name': 'AR882 Dose 1', 'type': 'DRUG', 'description': 'Solid Oral Capsule', 'armGroupLabels': ['Group 2', 'Group 3']}, {'name': 'AR882 Dose 2', 'type': 'DRUG', 'description': 'Solid Oral Capsule', 'armGroupLabels': ['Group 2']}, {'name': 'Allopurinol Tablet', 'type': 'DRUG', 'description': 'Solid tablet', 'armGroupLabels': ['Group 1', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (410)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (403)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (416)', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (417)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (402)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83713', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (404)', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (409)', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27410', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (406)', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '29577', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (408)', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Arthrosi Investigative Site (401)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Arthrosi Investigative Site (201)', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Arthrosi Investigative Site (303)', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'R Keenan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Arthrosi Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthrosi Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}