Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)

Last updated: April 11, 2025
Sponsor: Arthrosi Therapeutics
Overall Status: Active - Not Recruiting

Phase

3

Condition

Gout (Hyperuricemia)

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Treatment

AR882 50 mg

Placebo

AR882 75 mg

Clinical Study ID

NCT06439602
AR882-302
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

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 ≥ 7mg/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

Exclusion Criteria:

  • Malignancy within 5 years, except for successfully treated basal or squamous cellcarcinoma of the skin

  • Pregnant or breastfeeding

  • History of symptomatic kidney stones within the past 6 months

Study Design

Total Participants: 750
Treatment Group(s): 3
Primary Treatment: AR882 50 mg
Phase: 3
Study Start date:
June 26, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Arthrosi Investigative Site (202)

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Arthrosi Investigative Site (203)

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Arthrosi Investigative Site (201)

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Arthrosi Investigative Site (200)

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Arthrosi Investigative Site (500)

    Hong Kong, Central
    Hong Kong

    Site Not Available

  • Arthrosi Investigative Site (501)

    Hong Kong, Hong Kong Island
    Hong Kong

    Site Not Available

  • Arthrosi Investigative Site (300)

    Auckland, 1010
    New Zealand

    Site Not Available

  • Arthrosi Investigative Site (302)

    Auckland, 0632
    New Zealand

    Site Not Available

  • Arthrosi Investigative Site (304)

    Hamilton, 3200
    New Zealand

    Site Not Available

  • Arthrosi Investigative Site (303)

    Nelson, 7011
    New Zealand

    Site Not Available

  • Arthrosi Investigative Site (301)

    Rotorua, 3010
    New Zealand

    Site Not Available

  • Arthrosi Investigative Site (405)

    Hualien, 97002
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (404)

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (406)

    Kaohsiung City, 813
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (402)

    Taichung, 402
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (400)

    Taipei, 11217
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (403)

    Taipei, 112
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (401)

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (106)

    Foley, Alabama 36535
    United States

    Site Not Available

  • Arthrosi Investigative Site (139)

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Arthrosi Investigative Site (160)

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Arthrosi Investigative Site (112)

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • Arthrosi Investigative Site (114)

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Arthrosi Investigative Site (131)

    El Cajon, California 92108
    United States

    Site Not Available

  • Arthrosi Investigative Site (117)

    Encinitas, California 92024
    United States

    Site Not Available

  • Arthrosi Investigative Site (152)

    Montebello, California 90640
    United States

    Site Not Available

  • Arthrosi Investigative Site (138)

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Arthrosi Investigative Site (159)

    South Gate, California 90280
    United States

    Site Not Available

  • Arthrosi Investigative Site (161)

    Valencia, California 28277
    United States

    Site Not Available

  • Arthrosi Investigative Site (101)

    Aurora, Colorado 80014
    United States

    Site Not Available

  • Arthrosi Investigative Site (109)

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Arthrosi Investigative Site (118)

    Aventura, Florida 33180
    United States

    Site Not Available

  • Arthrosi Investigative Site (149)

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Arthrosi Investigative Site (115)

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Arthrosi Investigative Site (128)

    DeLand, Florida 32720
    United States

    Site Not Available

  • Arthrosi Investigative Site (143)

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Arthrosi Investigative Site (102)

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Arthrosi Investigative Site (156)

    Maitland, Florida 32751
    United States

    Site Not Available

  • Arthrosi Investigative Site (103)

    Miami, Florida 33176
    United States

    Site Not Available

  • Arthrosi Investigative Site (135)

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Arthrosi Investigative Site (157)

    Palmetto Bay, Florida 91355
    United States

    Site Not Available

  • Arthrosi Investigative Site (151)

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Arthrosi Investigative Site (164)

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Arthrosi Investigative Site (162)

    Lilburn, Georgia 30047
    United States

    Site Not Available

  • Arthrosi Investigative Site (133)

    Boise, Idaho 83713
    United States

    Site Not Available

  • Arthrosi Investigative Site (122)

    River Forest, Illinois 48109
    United States

    Site Not Available

  • Arthrosi Investigative Site (154)

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Arthrosi Investigative Site (108)

    New Orleans, Louisiana 70124
    United States

    Site Not Available

  • Arthrosi Investigative Site (144)

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Arthrosi Investigative Site (150)

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Arthrosi Investigative Site (121)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Arthrosi Investigative Site (105)

    Detroit, Michigan 48076
    United States

    Site Not Available

  • Arthrosi Investigative Site (153)

    Olive Branch, Mississippi 38654-3514
    United States

    Site Not Available

  • Arthrosi Investigative Site (119)

    Kansas City, Missouri 64151
    United States

    Site Not Available

  • Arthrosi Investigative Site (100)

    Binghamton, New York 13905
    United States

    Site Not Available

  • Arthrosi Investigative Site (113)

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Arthrosi Investigative Site (158)

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Arthrosi Investigative Site (155)

    New York, New York 10036
    United States

    Site Not Available

  • Arthrosi Investigative Site (137)

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Arthrosi Investigative Site (163)

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Arthrosi Investigative Site (140)

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Arthrosi Investigative Site (130)

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Arthrosi Investigative Site (148)

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Arthrosi Investigative Site (146)

    Dayton, Ohio 45429
    United States

    Site Not Available

  • Arthrosi Investigative Site (120)

    Hatboro, Pennsylvania 19040
    United States

    Site Not Available

  • Arthrosi Investigative Site (147)

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Arthrosi Investigative Site (132)

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Arthrosi Investigative Site (110)

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Arthrosi Investigative Site (104)

    Dallas, Texas 75251
    United States

    Site Not Available

  • Arthrosi Investigative Site (116)

    Graham, Texas 76450
    United States

    Site Not Available

  • Arthrosi Investigative Site (126)

    Lake Jackson, Texas 77566
    United States

    Site Not Available

  • Arthrosi Investigative Site (136)

    Missouri City, Texas 77459
    United States

    Site Not Available

  • Arthrosi Investigative Site (129)

    Plano, Texas 75024
    United States

    Site Not Available

  • Arthrosi Investigative Site (127)

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Arthrosi Investigative Site (107)

    Tomball, Texas 77375
    United States

    Site Not Available

  • Arthrosi Investigative Site (124)

    Tomball, Texas 77377
    United States

    Site Not Available

  • Arthrosi Investigative Site (142)

    Bountiful, Utah 98021
    United States

    Site Not Available

  • Arthrosi Investigative Site (145)

    Ogden, Utah 84405
    United States

    Site Not Available

  • Arthrosi Investigative Site (111)

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Arthrosi Investigative Site (118)

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Arthrosi Investigative Site (134)

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Arthrosi Investigative Site (141)

    Bothell, Washington 98021
    United States

    Site Not Available

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