Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

Completed · Phase 2

Conditions studied: Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic

In brief

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.

Key facts

Study ID

NCT05253833

Run by

Arthrosi Therapeutics

People needed

42

Starts

2022-08-12

Expected to finish

2024-10-28

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
• Pregnant or breastfeeding
• History of kidney stones

Where it is running

• 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

Full record on ClinicalTrials.gov

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