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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Arthrosi Investigative Site (105)
RECRUITING
Margate
Arthrosi Investigative Site (102)
RECRUITING
Miami
Pennsylvania
Arthrosi Investigative Site (103)
RECRUITING
Duncansville
Texas
Arthrosi Investigative Site (104)
RECRUITING
West Lake Hills
Contact Information
Primary
Director Clinical Operations
AR882-204@Arthrosi.com
+1 858-437-9123
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2027-01
Participants
Target number of participants: 25
Treatments
Experimental: AR882 75 mg + XOI
AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period in the Core Study Phase. Participants who complete the Core Study Phase can opt in to the Optional Extension Phase and continue to receive AR882 75 mg plus XOI high dose taken once daily for duration of an additional 6-month treatment period.
Related Therapeutic Areas
Sponsors
Leads: Arthrosi Therapeutics