AR882 plus a xanthine oxidase inhibitor to lower uric acid in people who failed uricase therapy
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
This will test whether giving AR882 together with a xanthine oxidase inhibitor (XOI) can lower serum uric acid and reduce tophi in people with gout who did not respond to uricase treatments like pegloticase.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Arthrosi Therapeutics Industry-sponsored |
| Locations | 8 sites (Margate, Florida and 7 other locations) |
| Trial ID | NCT07116746 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives AR882 75 mg co-administered with either a low- or high-dose xanthine oxidase inhibitor (XOI) to adults who previously failed uricase therapy. The main goals are to lower serum uric acid (sUA) and reduce clinically visible tophus burden. Eligible participants must have uncontrolled gout with at least one visible tophus, weigh at least 50 kg, and meet renal function limits; recent uricase exposure and certain medical conditions are exclusionary. The trial is being conducted at Arthrosi Investigative Sites in Florida and uses serial sUA measurements and tophus assessments to measure response.
Who should consider this trial
Good fit: Ideal candidates are adults with uncontrolled gout and at least one visible tophus who previously failed uricase treatment (including intolerance, infusion reactions, antibodies, or sUA rebound), weigh ≥50 kg, have serum creatinine <3.0 mg/dL with estimated CLcr ≥40 mL/min, and can attend the Florida site visits.
Not a fit: Patients who are pregnant or breastfeeding, have recent malignancy, recent symptomatic kidney stones, very poor kidney function, or who received uricase within the last 3 months are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could lower uric acid and shrink tophi, potentially reducing gout symptoms and flare risk for patients who failed prior uricase therapy.
How similar studies have performed: Xanthine oxidase inhibitors are a proven way to lower sUA, but combining AR882 with XOIs specifically to rescue patients who failed uricase therapy is a relatively novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Margate, Florida and 7 other locations
- Arthrosi Investigative Site (105) — Margate, Florida, United States (Recruiting)
- Arthrosi Investigative Site (102) — Miami, Florida, United States (Recruiting)
- Arthrosi Investigative Site (109) — Tampa, Florida, United States (Recruiting)
- Arthrosi Investigative Site (106) — Jackson, Mississippi, United States (Recruiting)
- Arthrosi Investigative Site (108) — Charlotte, North Carolina, United States (Recruiting)
- Arthrosi Investigative Site (103) — Duncansville, Pennsylvania, United States (Recruiting)
- Arthrosi Investigative Site (104) — West Lake Hills, Texas, United States (Recruiting)
- Arthrosi Investigative Site (107) — Bellevue, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Director Clinical Operations
- Email: AR882-204@Arthrosi.com
- Phone: +1 858-437-9123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.