Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
Running, not enrolling · Phase 2
Conditions studied: Gout, Gouty Arthritis, Hyperuricemia, Gout Chronic, Refractory Gout, Uncontrolled Gout, Tophaceous Gout
In brief
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.
Key facts
- Study ID
- NCT07116746
- Run by
- Arthrosi Therapeutics
- People needed
- 15
- Starts
- 2025-12-03
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arthrosi Investigative Site (105) — Margate, Florida, United States
- Arthrosi Investigative Site (102) — Miami, Florida, United States
- Arthrosi Investigative Site (109) — Tampa, Florida, United States
- Arthrosi Investigative Site (106) — Jackson, Mississippi, United States
- Arthrosi Investigative Site (108) — Charlotte, North Carolina, United States
- Arthrosi Investigative Site (103) — Duncansville, Pennsylvania, United States
- Arthrosi Investigative Site (104) — West Lake Hills, Texas, United States
- Arthrosi Investigative Site (107) — Bellevue, Washington, United States
Full record on ClinicalTrials.gov
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