Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
Launched by ARTHROSI THERAPEUTICS · Feb 21, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called AR882-301, is studying a new treatment called AR882 for patients with gout, a type of arthritis that causes painful swelling in the joints. The main goal is to see if AR882 can lower levels of uric acid in the blood, which is often high in people with gout, and to check how safe it is to use over a period of 12 months. Participants will be given either AR882 at two different doses or a placebo (which looks like the medication but has no active ingredients) to compare the effects.
To join this study, participants should be between the ages of 65 and 74 and have experienced at least two gout flare-ups in the past year. They should also weigh at least 50 kg (about 110 pounds) and need to have specific levels of uric acid in their blood. Some people may not be eligible, such as those who have had certain types of cancer recently or who are pregnant or breastfeeding. Participants can expect regular check-ups and monitoring during the trial and will contribute to important research that could help improve treatment options for gout in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • History of gout
- • Occurrence of ≥ 2 self-reported gout flares in the last 12 months
- • Body weight no less than 50 kg
- • Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
- • Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
- • Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 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
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
Omaha, Nebraska, United States
Horsham, Pennsylvania, United States
Fort Mill, South Carolina, United States
Hendersonville, Tennessee, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Garden Grove, California, United States
La Mesa, California, United States
La Palma, California, United States
Lincoln, California, United States
Lomita, California, United States
Long Beach, California, United States
Santa Monica, California, United States
Tarzana, California, United States
Thousand Oaks, California, United States
Tujunga, California, United States
Whittier, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Fort Collins, Colorado, United States
Cooper City, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Sanford, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Mandeville, Louisiana, United States
New Orleans, Louisiana, United States
Prairieville, Louisiana, United States
Oxon Hill, Maryland, United States
Rockville, Maryland, United States
Fall River, Massachusetts, United States
Bay City, Michigan, United States
Farmington Hills, Michigan, United States
Southfield, Michigan, United States
Gulfport, Mississippi, United States
Jackson, Mississippi, United States
Springfield, Missouri, United States
Town And Country, Missouri, United States
Lincoln, Nebraska, United States
Brooklyn, New York, United States
Hartsdale, New York, United States
Charlotte, North Carolina, United States
Fargo, North Dakota, United States
Mason, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charlston, South Carolina, United States
North Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Desoto, Texas, United States
Houston, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Tomball, Texas, United States
Clinton, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Kenosha, Wisconsin, United States
Overland Park, Kansas, United States
Raleigh, North Carolina, United States
Shelby, North Carolina, United States
Norman,, Oklahoma, United States
Peoria, Arizona, United States
Lilburn, Georgia, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Charlotte, North Carolina, United States
Prosper, Texas, United States
Bellevue, Washington, United States
Patients applied
Trial Officials
Robert Keenan, MD
Study Director
Arthrosi Therapeutics, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported