Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301) (NCT06846515) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
United States750 participantsStarted 2025-03-11
Plain-language 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
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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