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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

AR882 75 mg

Solid Oral Capsule

DRUG

XOI Low Dose

Solid Oral Tablet

DRUG

XOI 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