Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

Arthrosi Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Uncontrolled Gout; Gouty Arthritis; Gout Chronic; Hyperuricemia; Refractory Gout; Tophaceous Gout; Gout

Treatments: Drug: XOI Low Dose; Drug: XOI High Dose; Drug: AR882 75 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07116746

AR882-204

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

AR882 75 mg + XOI

Experimental group

Description:

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.

Treatment:

Drug: AR882 75 mg

Drug: XOI High Dose

Drug: XOI Low Dose