Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
NCT ID: NCT07116746
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2025-12-03
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
AR882 75 mg
Solid Oral Capsule
XOI Low Dose
Solid Oral Tablet
XOI High Dose
Solid Oral Tablet
Interventions
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AR882 75 mg
Solid Oral Capsule
XOI Low Dose
Solid Oral Tablet
XOI High Dose
Solid Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Arthrosi Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Keenan, MD
Role: STUDY_DIRECTOR
Arthrosi Therapeutics, Inc.
Locations
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Arthrosi Investigative Site (105)
Margate, Florida, United States
Arthrosi Investigative Site (102)
Miami, Florida, United States
Arthrosi Investigative Site (103)
Duncansville, Pennsylvania, United States
Arthrosi Investigative Site (104)
West Lake Hills, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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AR882-204
Identifier Type: -
Identifier Source: org_study_id