RecruitingPhase 2NCT07116746

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


Sponsor

Arthrosi Therapeutics

Enrollment

25 participants

Start Date

Dec 3, 2025

Study Type

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new gout drug called AR882 combined with a xanthine oxidase inhibitor (a standard gout medication) in people who had previously tried and failed treatment with uricase (a powerful enzyme-based gout therapy). The goal is to lower uric acid levels and reduce gout symptoms like tophi (hard lumps of uric acid crystals under the skin). **You may be eligible if...** - You have a history of uncontrolled gout - You have at least one visible tophus (lump under the skin caused by uric acid crystals) - Your last uricase treatment was at least 3 months ago - You weigh at least 50 kg (110 lbs) and have acceptable kidney function **You may NOT be eligible if...** - You have had cancer in the past 5 years (minor skin cancers excepted) - You are pregnant or breastfeeding - You have had symptomatic kidney stones in the past 6 months - You have received a uricase drug (pegloticase, rasburicase) within the last 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAR882 75 mg

Solid Oral Capsule

DRUGXOI Low Dose

Solid Oral Tablet

DRUGXOI High Dose

Solid Oral Tablet


Locations(8)

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

View Full Details on ClinicalTrials.gov

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NCT07116746


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