Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
Launched by ARTHROSI THERAPEUTICS · Aug 7, 2025
Trial Information
Current as of September 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for people with gout who have not responded well to previous uricase therapies, such as pegloticase. Gout is a condition caused by high levels of uric acid in the blood, which can lead to painful joint swelling and lumps called tophi. This study will test whether combining two medicines, AR882 and a type of drug called a xanthine oxidase inhibitor (XOI), can better lower uric acid levels and reduce these tophi in people whose gout has been hard to control.
To join the study, participants need to have a history of uncontrolled gout with at least one visible tophus, be at least 18 years old, weigh at least 50 kg (about 110 pounds), and have had their last uricase treatment at least three months ago. People with certain kidney problems, recent cancer, pregnancy, or recent treatment with uricase drugs won’t be eligible. Those who participate will receive the study medicines and be monitored to see how well the treatment works and if it is safe. This trial is not yet open for recruiting, but it aims to help people with difficult-to-treat gout find better options to manage their condition.
Gender
ALL
Eligibility 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
About Arthrosi Therapeutics
Arthrosi Therapeutics is a pioneering biopharmaceutical company focused on the development of innovative therapies for the treatment of osteoarthritis and related musculoskeletal disorders. Leveraging cutting-edge research and advanced drug delivery systems, Arthrosi aims to address unmet medical needs by providing effective, safe, and patient-centric solutions. Committed to scientific excellence and collaboration, the company actively engages in clinical trials to validate its therapeutic approaches, fostering a transformative impact on patient outcomes in the realm of joint health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Robert Keenan, MD
Study Director
Arthrosi Therapeutics, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported