Status:
COMPLETED
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
Lead Sponsor:
Arthrosi Therapeutics
Conditions:
Gout
Arthritis, Gouty
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 allopur...
Eligibility Criteria
Inclusion
- History of gout
- 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
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- Pregnant or breastfeeding
- History of kidney stones
Key Trial Info
Start Date :
August 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05253833
Start Date
August 12 2022
End Date
October 28 2024
Last Update
January 29 2025
Active Locations (12)
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1
Arthrosi Investigative Site (410)
Birmingham, Alabama, United States, 35233
2
Arthrosi Investigative Site (403)
Phoenix, Arizona, United States, 85032
3
Arthrosi Investigative Site (416)
Sun City, Arizona, United States, 85351
4
Arthrosi Investigative Site (417)
Tucson, Arizona, United States, 85704