Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
NCT ID: NCT05253833
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2022-08-12
2024-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Allopurinol once daily for 24 weeks
Allopurinol Tablet
Solid tablet
Group 2
AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
AR882 Dose 1
Solid Oral Capsule
AR882 Dose 2
Solid Oral Capsule
Group 3
AR882 Dose 1 + Allopurinol for 24 weeks
AR882 Dose 1
Solid Oral Capsule
Allopurinol Tablet
Solid tablet
Interventions
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AR882 Dose 1
Solid Oral Capsule
AR882 Dose 2
Solid Oral Capsule
Allopurinol Tablet
Solid tablet
Eligibility Criteria
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Inclusion Criteria
* at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
* Patients who are NOT on approved ULT must have sUA \> 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2
Exclusion Criteria
* Pregnant or breastfeeding
* History of kidney stones
18 Years
75 Years
ALL
No
Sponsors
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Arthrosi Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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R Keenan, MD
Role: STUDY_CHAIR
Arthrosi Therapeutics
Locations
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Arthrosi Investigative Site (410)
Birmingham, Alabama, United States
Arthrosi Investigative Site (403)
Phoenix, Arizona, United States
Arthrosi Investigative Site (416)
Sun City, Arizona, United States
Arthrosi Investigative Site (417)
Tucson, Arizona, United States
Arthrosi Investigative Site (402)
Tampa, Florida, United States
Arthrosi Investigative Site (404)
Boise, Idaho, United States
Arthrosi Investigative Site (409)
Ann Arbor, Michigan, United States
Arthrosi Investigative Site (406)
Greensboro, North Carolina, United States
Arthrosi Investigative Site (408)
Myrtle Beach, South Carolina, United States
Arthrosi Investigative Site (401)
Dallas, Texas, United States
Arthrosi Investigative Site (201)
Auckland, , New Zealand
Arthrosi Investigative Site (303)
Taichung, , Taiwan
Countries
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Other Identifiers
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AR882-203
Identifier Type: -
Identifier Source: org_study_id
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