← Back to all trials
Active Not Recruiting
NCT06846515
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
Conditions: Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 750
Sponsor: Arthrosi Therapeutics
Location: Arthrosi Investigative Site (620) Birmingham Alabama
Summary
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
Eligibility Criteria
Inclusion Criteria:
* History of gout
* Occurrence of ≥ 2 self-reported gout flares in the last 12 months
* Body weight no less than 50 kg
* Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min
Exclusion Criteria:
* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* Pregnant or breastfeeding
* History of symptomatic kidney stones within the past 6 months
Source: ClinicalTrials.gov (NCT06846515). StuddyBuddy aggregates publicly available trial information.