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

Condition(s) studied

Investigational drug(s) / intervention(s)

AR882 75 mg: Solid Oral Capsule

XOI Low Dose: Solid Oral Tablet

XOI High Dose: Solid Oral Tablet

Study 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

Primary outcome measure(s)

• Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 — 24 weeks
  Proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6

Trial sites (8)