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

May 11, 2026 updated by: Arthrosi Therapeutics

A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

818

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Arthrosi Investigative Site (202)
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Arthrosi Investigative Site (200)
  • Hong Kong
    • Central
      • Hong Kong, Central, Hong Kong
        • Arthrosi Investigative Site (500)
    • Hong Kong Island
      • Hong Kong, Hong Kong Island, Hong Kong
        • Arthrosi Investigative Site (501)
  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 1010
        • Arthrosi Investigative Site (300)
    • Hamilton
      • Hamilton, Hamilton, New Zealand, 3200
        • Arthrosi Investigative Site (304)
    • New Zealand
      • Auckland, New Zealand, New Zealand, 0632
        • Arthrosi Investigative Site (302)
      • Nelson, New Zealand, New Zealand, 7011
        • Arthrosi Investigative Site (303)
      • Rotorua, New Zealand, New Zealand, 3010
        • Arthrosi Investigative Site (301)
  • Taiwan
      • Kaohsiung City, Taiwan, 813
        • Arthrosi Investigative Site (406)
      • Taichung, Taiwan, 402
        • Arthrosi Investigative Site (402)
    • Taiwan
      • Hualien City, Taiwan, Taiwan, 97002
        • Arthrosi Investigative Site (405)
      • Kaohsiung City, Taiwan, Taiwan, 833
        • Arthrosi Investigative Site (404)
      • Taipei, Taiwan, Taiwan, 11217
        • Arthrosi Investigative Site (400)
      • Taipei, Taiwan, Taiwan, 112
        • Arthrosi Investigative Site (403)
      • Taoyuan City, Taiwan, Taiwan, 333
        • Arthrosi Investigative Site (401)
  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • Arthrosi Investigative Site (106)
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Arthrosi Investigative Site (139)
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Arthrosi Investigative Site (160)
      • Phoenix, Arizona, United States, 85037
        • Arthrosi Investigative Site (112)
      • Tempe, Arizona, United States, 85281
        • Arthrosi Investigative Site (114)
    • California
      • El Cajon, California, United States, 92108
        • Arthrosi Investigative Site (131)
      • Encinitas, California, United States, 92024
        • Arthrosi Investigative Site (117)
      • Rancho Cucamonga, California, United States, 91730
        • Arthrosi Investigative Site (138)
      • Valencia, California, United States, 28277
        • Arthrosi Investigative Site (161)
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Arthrosi Investigative Site (101)
    • Florida
      • Clearwater, Florida, United States, 33756
        • Arthrosi Investigative Site (149)
      • Coral Gables, Florida, United States, 33134
        • Arthrosi Investigative Site (115)
      • DeLand, Florida, United States, 32720
        • Arthrosi Investigative Site (128)
      • Hollywood, Florida, United States, 33024
        • Arthrosi Investigative Site (102)
      • Maitland, Florida, United States, 32751
        • Arthrosi Investigative Site (156)
      • Miami, Florida, United States, 33176
        • Arthrosi Investigative Site (103)
      • Palmetto Bay, Florida, United States, 91355
        • Arthrosi Investigative Site (157)
      • Winter Haven, Florida, United States, 33880
        • Arthrosi Investigative Site (151)
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Arthrosi Investigative Site (164)
      • Lilburn, Georgia, United States, 30047
        • Arthrosi Investigative Site (162)
    • Idaho
      • Boise, Idaho, United States, 83713
        • Arthrosi Investigative Site (133)
    • Illinois
      • River Forest, Illinois, United States, 48109
        • Arthrosi Investigative Site (122)
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Arthrosi Investigative Site (154)
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Arthrosi Investigative Site (144)
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Arthrosi Investigative Site (150)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Arthrosi Investigative Site (121)
      • Detroit, Michigan, United States, 48076
        • Arthrosi Investigative Site (105)
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654-3514
        • Arthrosi Investigative Site (153)
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • Arthrosi Investigative Site (119)
    • New York
      • Brooklyn, New York, United States, 11215
        • Arthrosi Investigative Site (158)
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Arthrosi Investigative Site (137)
      • Shelby, North Carolina, United States, 28150
        • Arthrosi Investigative Site (140)
      • Wilmington, North Carolina, United States, 28403
        • Arthrosi Investigative Site (130)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Arthrosi Investigative Site (148)
      • Dayton, Ohio, United States, 45429
        • Arthrosi Investigative Site (146)
    • Pennsylvania
      • Hatboro, Pennsylvania, United States, 19040
        • Arthrosi Investigative Site (120)
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Arthrosi Investigative Site (147)
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Arthrosi Investigative Site (132)
    • Texas
      • Amarillo, Texas, United States, 79106
        • Arthrosi Investigative Site (110)
      • Dallas, Texas, United States, 75251
        • Arthrosi Investigative Site (104)
      • Graham, Texas, United States, 76450
        • Arthrosi Investigative Site (116)
      • Lake Jackson, Texas, United States, 77566
        • Arthrosi Investigative Site (126)
      • Missouri City, Texas, United States, 77459
        • Arthrosi Investigative Site (136)
      • Plano, Texas, United States, 75024
        • Arthrosi Investigative Site (129)
      • Round Rock, Texas, United States, 78681
        • Arthrosi Investigative Site (127)
      • Tomball, Texas, United States, 77375
        • Arthrosi Investigative Site (107)
      • Tomball, Texas, United States, 77377
        • Arthrosi Investigative Site (124)
    • Utah
      • Bountiful, Utah, United States, 98021
        • Arthrosi Investigative Site (142)
      • Ogden, Utah, United States, 84405
        • Arthrosi Investigative Site (145)
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Arthrosi Investigative Site (111)
      • Hampton, Virginia, United States, 23666
        • Arthrosi Investigative Site (118)
      • Winchester, Virginia, United States, 22601
        • Arthrosi Investigative Site (134)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AR882 50 mg
AR882 50 mg taken once daily for 12 months
Drug: AR882 50 mg
Solid Oral Capsule
Experimental: AR882 75 mg
AR882 75 mg taken once daily for 12 months
Drug: AR882 75 mg
Solid Oral Capsule
Placebo Comparator: Placebo
AR882 matching placebo taken once daily for 12 months
Drug: Placebo
Matching Solid Oral Capsule Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Time Frame: 24 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12
Time Frame: 12 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12
12 weeks
No gout flares from the end of month 9 to the end of month 12
Time Frame: 12 weeks
Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12
12 weeks
Change in tophus burden by month 12
Time Frame: 48 weeks
Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method
48 weeks
Incidence of Adverse Events
Time Frame: 56 weeks
Treatment Emergent Adverse Events and Serious Adverse Event incidence
56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrosi Therapeutics

Investigators

  • Study Director: Robert Keenan, MD, Arthrosi Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Actual)

March 20, 2026

Study Completion (Actual)

April 10, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR882-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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