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Clinical Trials in the USA / NCT07116746
Active, not recruiting Phase 2

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

NCT07116746 · tracked via the Priya Life Science USA tracker
Sponsor
Arthrosi Therapeutics
Phase
Phase 2
Started
2025-12-03
Last updated
2026-05-15

Condition(s) studied

GoutGouty ArthritisHyperuricemiaGout ChronicRefractory GoutUncontrolled GoutTophaceous Gout

Investigational drug(s) / intervention(s)

AR882 75 mgXOI Low DoseXOI High Dose

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
Arthrosi Investigative Site (105) Margate Florida
Arthrosi Investigative Site (102) Miami Florida
Arthrosi Investigative Site (109) Tampa Florida
Arthrosi Investigative Site (106) Jackson Mississippi
Arthrosi Investigative Site (108) Charlotte North Carolina
Arthrosi Investigative Site (103) Duncansville Pennsylvania
Arthrosi Investigative Site (104) West Lake Hills Texas
Arthrosi Investigative Site (107) Bellevue Washington

Other trials for the same condition

A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants Recruiting
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. Active, not recruiting
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE) Recruiting
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout Recruiting
A Study of Dotinurad Versus Allopurinol in Participants With Gout Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07116746 on ClinicalTrials.gov ↗ ← All trials in the USA