Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
NCT ID: NCT06439602
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
750 participants
INTERVENTIONAL
2024-06-26
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AR882 50 mg
AR882 50 mg taken once daily for 12 months
AR882 50 mg
Solid Oral Capsule
AR882 75 mg
AR882 75 mg taken once daily for 12 months
AR882 75 mg
Solid Oral Capsule
Placebo
AR882 matching placebo taken once daily for 12 months
Placebo
Matching Solid Oral Capsule Placebo
Interventions
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AR882 50 mg
Solid Oral Capsule
AR882 75 mg
Solid Oral Capsule
Placebo
Matching Solid Oral Capsule Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breastfeeding
* History of symptomatic kidney stones within the past 6 months
18 Years
85 Years
ALL
No
Sponsors
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Arthrosi Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Keenan, MD
Role: STUDY_DIRECTOR
Arthrosi Therapeutics, Inc.
Locations
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Arthrosi Investigative Site (106)
Foley, Alabama, United States
Arthrosi Investigative Site (139)
Anchorage, Alaska, United States
Arthrosi Investigative Site (160)
Peoria, Arizona, United States
Arthrosi Investigative Site (112)
Phoenix, Arizona, United States
Arthrosi Investigative Site (114)
Tempe, Arizona, United States
Arthrosi Investigative Site (131)
El Cajon, California, United States
Arthrosi Investigative Site (117)
Encinitas, California, United States
Arthrosi Investigative Site (138)
Rancho Cucamonga, California, United States
Arthrosi Investigative Site (161)
Valencia, California, United States
Arthrosi Investigative Site (101)
Aurora, Colorado, United States
Arthrosi Investigative Site (149)
Clearwater, Florida, United States
Arthrosi Investigative Site (115)
Coral Gables, Florida, United States
Arthrosi Investigative Site (128)
DeLand, Florida, United States
Arthrosi Investigative Site (102)
Hollywood, Florida, United States
Arthrosi Investigative Site (156)
Maitland, Florida, United States
Arthrosi Investigative Site (103)
Miami, Florida, United States
Arthrosi Investigative Site (157)
Palmetto Bay, Florida, United States
Arthrosi Investigative Site (151)
Winter Haven, Florida, United States
Arthrosi Investigative Site (164)
Atlanta, Georgia, United States
Arthrosi Investigative Site (162)
Lilburn, Georgia, United States
Arthrosi Investigative Site (133)
Boise, Idaho, United States
Arthrosi Investigative Site (122)
River Forest, Illinois, United States
Arthrosi Investigative Site (154)
Wichita, Kansas, United States
Arthrosi Investigative Site (144)
New Orleans, Louisiana, United States
Arthrosi Investigative Site (150)
Hagerstown, Maryland, United States
Arthrosi Investigative Site (121)
Ann Arbor, Michigan, United States
Arthrosi Investigative Site (105)
Detroit, Michigan, United States
Arthrosi Investigative Site (153)
Olive Branch, Mississippi, United States
Arthrosi Investigative Site (119)
Kansas City, Missouri, United States
Arthrosi Investigative Site (158)
Brooklyn, New York, United States
Arthrosi Investigative Site (137)
Greensboro, North Carolina, United States
Arthrosi Investigative Site (140)
Shelby, North Carolina, United States
Arthrosi Investigative Site (130)
Wilmington, North Carolina, United States
Arthrosi Investigative Site (148)
Cleveland, Ohio, United States
Arthrosi Investigative Site (146)
Dayton, Ohio, United States
Arthrosi Investigative Site (120)
Hatboro, Pennsylvania, United States
Arthrosi Investigative Site (147)
Myrtle Beach, South Carolina, United States
Arthrosi Investigative Site (132)
Rapid City, South Dakota, United States
Arthrosi Investigative Site (110)
Amarillo, Texas, United States
Arthrosi Investigative Site (104)
Dallas, Texas, United States
Arthrosi Investigative Site (116)
Graham, Texas, United States
Arthrosi Investigative Site (126)
Lake Jackson, Texas, United States
Arthrosi Investigative Site (136)
Missouri City, Texas, United States
Arthrosi Investigative Site (129)
Plano, Texas, United States
Arthrosi Investigative Site (127)
Round Rock, Texas, United States
Arthrosi Investigative Site (107)
Tomball, Texas, United States
Arthrosi Investigative Site (124)
Tomball, Texas, United States
Arthrosi Investigative Site (142)
Bountiful, Utah, United States
Arthrosi Investigative Site (145)
Ogden, Utah, United States
Arthrosi Investigative Site (111)
Hampton, Virginia, United States
Arthrosi Investigative Site (118)
Hampton, Virginia, United States
Arthrosi Investigative Site (134)
Winchester, Virginia, United States
Arthrosi Investigative Site (202)
Botany, New South Wales, Australia
Arthrosi Investigative Site (200)
Camberwell, Victoria, Australia
Arthrosi Investigative Site (500)
Hong Kong, Central, Hong Kong
Arthrosi Investigative Site (501)
Hong Kong, Hong Kong Island, Hong Kong
Arthrosi Investigative Site (300)
Auckland, Auckland, New Zealand
Arthrosi Investigative Site (304)
Hamilton, Hamilton, New Zealand
Arthrosi Investigative Site (302)
Auckland, New Zealand, New Zealand
Arthrosi Investigative Site (303)
Nelson, New Zealand, New Zealand
Arthrosi Investigative Site (301)
Rotorua, New Zealand, New Zealand
Arthrosi Investigative Site (405)
Hualien City, Taiwan, Taiwan
Arthrosi Investigative Site (404)
Kaohsiung City, Taiwan, Taiwan
Arthrosi Investigative Site (400)
Taipei, Taiwan, Taiwan
Arthrosi Investigative Site (403)
Taipei, Taiwan, Taiwan
Arthrosi Investigative Site (401)
Taoyuan, Taiwan, Taiwan
Arthrosi Investigative Site (406)
Kaohsiung City, , Taiwan
Arthrosi Investigative Site (402)
Taichung, , Taiwan
Countries
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Other Identifiers
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AR882-302
Identifier Type: -
Identifier Source: org_study_id
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