A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout
Status: Active_not_recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Arthrosi Investigative Site (620)
Birmingham
Arthrosi Investigative Site (616)
Huntsville
Arkansas
Arthrosi Investigative Site (617)
Little Rock
Arizona
Arthrosi Investigative Site (680)
Peoria
Arthrosi Investigative Site (640)
Phoenix
California
Arthrosi Investigative Site (614)
Garden Grove
Arthrosi Investigative Site (618)
La Mesa
Arthrosi Investigative Site (687)
La Mesa
Arthrosi Investigative Site (655)
La Palma
Arthrosi Investigative Site (632)
Lincoln
Arthrosi Investigative Site (605)
Lomita
Arthrosi Investigative Site (675)
Long Beach
Arthrosi Investigative Site (603)
Santa Monica
Arthrosi Investigative Site (672)
Tarzana
Arthrosi Investigative Site (656)
Thousand Oaks
Colorado
Arthrosi Investigative Site (660)
Aurora
Arthrosi Investigative Site (669)
Colorado Springs
Arthrosi Investigative Site (612)
Fort Collins
Florida
Arthrosi Investigative Site (665)
Cooper City
Arthrosi Investigative Site (613)
Jupiter
Arthrosi Investigative Site (611)
Miami
Arthrosi Investigative Site (644)
Miami
Arthrosi Investigative Site (694)
Palmetto Bay
Arthrosi Investigative Site (615)
Sanford
Arthrosi Investigative Site (600)
Tampa
Georgia
Arthrosi Investigative Site (673)
Atlanta
Arthrosi Investigative Site (682)
Lilburn
Arthrosi Investigative Site (652)
Marietta
Hawaii
Arthrosi Investigative Site (658)
Honolulu
Idaho
Arthrosi Investigative Site (676)
Boise
Arthrosi Investigative Site (634)
Meridian
Illinois
Arthrosi Investigative Site (657)
Chicago
Arthrosi Investigative Site (648)
Melrose Park
Indiana
Arthrosi Investigative Site (678)
Indianapolis
Kansas
Arthrosi Investigative Site (679)
Overland Park
Kentucky
Arthrosi Investigative Site (674)
Louisville
Louisiana
Arthrosi Investigative Site (627)
Mandeville
Arthrosi Investigative Site (650)
New Orleans
Arthrosi Investigative Site (641)
Prairieville
Massachusetts
Arthrosi Investigative Site (636)
Fall River
Maryland
Arthrosi Investigative Site (662)
Oxon Hill
Arthrosi Investigative Site (653)
Rockville
Michigan
Arthrosi Investigative Site (622)
Bay City
Arthrosi Investigative Site (628)
Farmington Hills
Arthrosi Investigative Site (645)
Southfield
Missouri
Arthrosi Investigative Site (637)
Springfield
Arthrosi Investigative Site (626)
Town And Country
Mississippi
Arthrosi Investigative Site (633)
Gulfport
Arthrosi Investigative Site (635)
Jackson
Arthrosi Investigative Site (693)
Olive Branch
Montana
Arthrosi Investigative Site (664)
Missoula
North Carolina
Arthrosi Investigative Site (625)
Charlotte
Arthrosi Investigative Site (681)
Charlotte
Arthrosi Investigative Site (683)
Raleigh
Arthrosi Investigative Site (649)
Shelby
North Dakota
Arthrosi Investigative Site (666)
Fargo
Nebraska
Arthrosi Investigative Site (610)
Lincoln
Arthrosi Investigative Site (651)
Omaha
Arthrosi Investigative Site (684)
Omaha
Nevada
Arthrosi Investigative Site (686)
Las Vegas
New York
Arthrosi Investigative Site (661)
Brooklyn
Arthrosi Investigative Site (663)
Hartsdale
Ohio
Arthrosi Investigative Site (671)
Mason
Oklahoma
Arthrosi Investigative Site (631)
Norman
Arthrosi Investigative Site (642)
Tulsa
Pennsylvania
Arthrosi Investigative Site (647)
Horsham
Arthrosi Investigative Site (623)
Philadelphia
South Carolina
Arthrosi Investigative Site (638)
Charleston
Arthrosi Investigative Site (604)
Fort Mill
Arthrosi Investigative Site (608)
North Charleston
Tennessee
Arthrosi Investigative Site (619)
Chattanooga
Arthrosi Investigative Site (624)
Hendersonville
Texas
Arthrosi Investigative Site (670)
Amarillo
Arthrosi Investigative Site (677)
Austin
Arthrosi Investigative Site (690)
Dallas
Arthrosi Investigative Site (639)
Desoto
Arthrosi Investigative Site (601)
Houston
Arthrosi Investigative Site (688)
Plano
Arthrosi Investigative Site (689)
Prosper
Arthrosi Investigative Site (607)
Sugar Land
Arthrosi Investigative Site (646)
Tomball
Arthrosi Investigative Site (659)
Tomball
Utah
Arthrosi Investigative Site (643)
Clinton
Arthrosi Investigative Site (609)
Salt Lake City
Arthrosi Investigative Site (654)
Salt Lake City
Virginia
Arthrosi Investigative Site (606)
Charlottesville
Arthrosi Investigative Site (691)
Winchester
Washington
Arthrosi Investigative Site (685)
Bellevue
Wisconsin
Arthrosi Investigative Site (668)
Kenosha
Time Frame
Start Date: 2025-03-11
Completion Date: 2026-04
Participants
Target number of participants: 750
Treatments
Experimental: AR882 50 mg
AR882 50 mg taken once daily for 12 months
Experimental: AR882 75 mg
AR882 75 mg taken once daily for 12 months
Placebo_comparator: Placebo
AR882 matching placebo taken once daily for 12 months
Sponsors
Leads: Arthrosi Therapeutics