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
Arthrosi Therapeutics
25 participants
Dec 3, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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
Interventions
Solid Oral Capsule
Solid Oral Tablet
Solid Oral Tablet
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT07116746