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NCT Number: NCT07116746

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gout Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Chronic Gouty Arthritis Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Refractory Gout Rheumatic Diseases Tophaceous Gout Uncontrolled Gout

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arthrosi Investigative Site (105), Margate, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AR882 75 mg

Drug

Solid Oral Capsule

XOI Low Dose

Drug

Solid Oral Tablet

XOI High Dose

Drug

Solid Oral Tablet

Primary outcomes

  1. Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

    Time frame: 24 weeks

    Proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

Secondary outcomes

  1. Change in tophus burden by month 6

    Time frame: 24 weeks

    Change in tophus burden by measurement of targeted tophi area at Month 6

  2. Incidence of Adverse Events

    Time frame: 56 weeks

    Treatment Emergent Adverse Events and Serious Adverse Event incidence

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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