Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

A Phase 2, Multicenter, Open-label, Efficacy and Safety Study of AR882 and XOI Co-administration in Participants With Uncontrolled Gout Who Have Previously Failed Uricase Treatment

This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.

Inclusion Criteria:

• History of uncontrolled gout
• Presence of ≥1 clinically visible tophus
• Last uricase infusion occurred ≥3 months
• Body weight no less than 50 kg
• Serum creatinine must be < 3.0 mg/dL and estimated CLcr ≥ 40 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
• Received pegloticase, rasburicase or other experimental uricases within the last 3 months