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 (68) 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
Alaska
Arthrosi Investigative Site (139)
Anchorage
Alabama
Arthrosi Investigative Site (106)
Foley
Arizona
Arthrosi Investigative Site (160)
Peoria
Arthrosi Investigative Site (112)
Phoenix
Arthrosi Investigative Site (114)
Tempe
California
Arthrosi Investigative Site (131)
El Cajon
Arthrosi Investigative Site (117)
Encinitas
Arthrosi Investigative Site (138)
Rancho Cucamonga
Arthrosi Investigative Site (161)
Valencia
Colorado
Arthrosi Investigative Site (101)
Aurora
Florida
Arthrosi Investigative Site (149)
Clearwater
Arthrosi Investigative Site (115)
Coral Gables
Arthrosi Investigative Site (128)
Deland
Arthrosi Investigative Site (102)
Hollywood
Arthrosi Investigative Site (156)
Maitland
Arthrosi Investigative Site (103)
Miami
Arthrosi Investigative Site (157)
Palmetto Bay
Arthrosi Investigative Site (151)
Winter Haven
Georgia
Arthrosi Investigative Site (164)
Atlanta
Arthrosi Investigative Site (162)
Lilburn
Idaho
Arthrosi Investigative Site (133)
Boise
Illinois
Arthrosi Investigative Site (122)
River Forest
Kansas
Arthrosi Investigative Site (154)
Wichita
Louisiana
Arthrosi Investigative Site (144)
New Orleans
Maryland
Arthrosi Investigative Site (150)
Hagerstown
Michigan
Arthrosi Investigative Site (121)
Ann Arbor
Arthrosi Investigative Site (105)
Detroit
Missouri
Arthrosi Investigative Site (119)
Kansas City
Mississippi
Arthrosi Investigative Site (153)
Olive Branch
North Carolina
Arthrosi Investigative Site (137)
Greensboro
Arthrosi Investigative Site (140)
Shelby
Arthrosi Investigative Site (130)
Wilmington
New York
Arthrosi Investigative Site (158)
Brooklyn
Ohio
Arthrosi Investigative Site (148)
Cleveland
Arthrosi Investigative Site (146)
Dayton
Pennsylvania
Arthrosi Investigative Site (120)
Hatboro
South Carolina
Arthrosi Investigative Site (147)
Myrtle Beach
South Dakota
Arthrosi Investigative Site (132)
Rapid City
Texas
Arthrosi Investigative Site (110)
Amarillo
Arthrosi Investigative Site (104)
Dallas
Arthrosi Investigative Site (116)
Graham
Arthrosi Investigative Site (126)
Lake Jackson
Arthrosi Investigative Site (136)
Missouri City
Arthrosi Investigative Site (129)
Plano
Arthrosi Investigative Site (127)
Round Rock
Arthrosi Investigative Site (107)
Tomball
Arthrosi Investigative Site (124)
Tomball
Utah
Arthrosi Investigative Site (142)
Bountiful
Arthrosi Investigative Site (145)
Ogden
Virginia
Arthrosi Investigative Site (111)
Hampton
Arthrosi Investigative Site (118)
Hampton
Arthrosi Investigative Site (134)
Winchester
Other Locations
Australia
Arthrosi Investigative Site (202)
Botany
Arthrosi Investigative Site (200)
Camberwell
Hong Kong Special Administrative Region
Arthrosi Investigative Site (500)
Hong Kong
Arthrosi Investigative Site (501)
Hong Kong
New Zealand
Arthrosi Investigative Site (300)
Auckland
Arthrosi Investigative Site (302)
Auckland
Arthrosi Investigative Site (304)
Hamilton
Arthrosi Investigative Site (303)
Nelson
Arthrosi Investigative Site (301)
Rotorua
Taiwan
Arthrosi Investigative Site (405)
Hualien City
Arthrosi Investigative Site (404)
Kaohsiung City
Arthrosi Investigative Site (406)
Kaohsiung City
Arthrosi Investigative Site (402)
Taichung
Arthrosi Investigative Site (400)
Taipei
Arthrosi Investigative Site (403)
Taipei
Arthrosi Investigative Site (401)
Taoyuan
Time Frame
Start Date: 2024-06-26
Completion Date: 2026-11
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