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
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