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

RECRUITINGPhase 2Sponsored by Arthrosi Therapeutics
Actively Recruiting
PhasePhase 2
SponsorArthrosi Therapeutics
Started2025-12-03
Est. completion2026-07
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT07116746

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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

Conditions8

ArthritisGoutGout ChronicGouty ArthritisHyperuricemiaRefractory GoutTophaceous GoutUncontrolled Gout

Locations8 sites

Arthrosi Investigative Site (105)
Margate, Florida, 33063
Arthrosi Investigative Site (102)
Miami, Florida, 33155
Arthrosi Investigative Site (109)
Tampa, Florida, 33609
Arthrosi Investigative Site (106)
Jackson, Mississippi, 39202
Arthrosi Investigative Site (108)
Charlotte, North Carolina, 28202

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