Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Arthrosi Investigative Site (620)
      • Huntsville, Alabama, United States, 35801
        • Arthrosi Investigative Site (616)
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Arthrosi Investigative Site (680)
      • Phoenix, Arizona, United States, 85018
        • Arthrosi Investigative Site (640)
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arthrosi Investigative Site (617)
    • California
      • Garden Grove, California, United States, 92844
        • Arthrosi Investigative Site (614)
      • La Mesa, California, United States, 91942
        • Arthrosi Investigative Site (618)
      • La Mesa, California, United States, 91942
        • Arthrosi Investigative Site (687)
      • La Palma, California, United States, 90623
        • Arthrosi Investigative Site (655)
      • Lincoln, California, United States, 95648
        • Arthrosi Investigative Site (632)
      • Lomita, California, United States, 90717
        • Arthrosi Investigative Site (605)
      • Long Beach, California, United States, 90806
        • Arthrosi Investigative Site (675)
      • Santa Monica, California, United States, 90404
        • Arthrosi Investigative Site (603)
      • Tarzana, California, United States, 91356
        • Arthrosi Investigative Site (672)
      • Thousand Oaks, California, United States, 91360
        • Arthrosi Investigative Site (656)
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Arthrosi Investigative Site (660)
      • Colorado Springs, Colorado, United States, 80909
        • Arthrosi Investigative Site (669)
      • Fort Collins, Colorado, United States, 80528
        • Arthrosi Investigative Site (612)
    • Florida
      • Cooper City, Florida, United States, 33024
        • Arthrosi Investigative Site (665)
      • Jupiter, Florida, United States, 33458
        • Arthrosi Investigative Site (613)
      • Miami, Florida, United States, 33173
        • Arthrosi Investigative Site (611)
      • Miami, Florida, United States, 33176
        • Arthrosi Investigative Site (644)
      • Palmetto Bay, Florida, United States, 33157
        • Arthrosi Investigative Site (694)
      • Sanford, Florida, United States, 32771
        • Arthrosi Investigative Site (615)
      • Tampa, Florida, United States, 33609
        • Arthrosi Investigative Site (600)
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Arthrosi Investigative Site (673)
      • Marietta, Georgia, United States, 30060
        • Arthrosi Investigative Site (652)
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Arthrosi Investigative Site (658)
    • Idaho
      • Boise, Idaho, United States, 83713
        • Arthrosi Investigative Site (676)
      • Meridian, Idaho, United States, 83642
        • Arthrosi Investigative Site (634)
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Arthrosi Investigative Site (657)
      • Melrose Park, Illinois, United States, 60160
        • Arthrosi Investigative Site (648)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Arthrosi Investigative Site (678)
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Arthrosi Investigative Site (679)
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Arthrosi Investigative Site (674)
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Arthrosi Investigative Site (627)
      • New Orleans, Louisiana, United States, 70115
        • Arthrosi Investigative Site (650)
      • Prairieville, Louisiana, United States, 70769
        • Arthrosi Investigative Site (641)
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Arthrosi Investigative Site (662)
      • Rockville, Maryland, United States, 20852
        • Arthrosi Investigative Site (653)
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Arthrosi Investigative Site (636)
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Arthrosi Investigative Site (628)
      • Southfield, Michigan, United States, 48076
        • Arthrosi Investigative Site (645)
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Arthrosi Investigative Site (633)
      • Jackson, Mississippi, United States, 39202
        • Arthrosi Investigative Site (635)
      • Olive Branch, Mississippi, United States, 38654
        • Arthrosi Investigative Site (693)
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Arthrosi Investigative Site (637)
      • Town and Country, Missouri, United States, 63017
        • Arthrosi Investigative Site (626)
    • Montana
      • Missoula, Montana, United States, 59808
        • Arthrosi Investigative Site (664)
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Arthrosi Investigative Site (610)
      • Omaha, Nebraska, United States, 68114
        • Arthrosi Investigative Site (684)
      • Omaha, Nebraska, United States, 68144
        • Arthrosi Investigative Site (651)
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Arthrosi Investigative Site (686)
    • New York
      • Brooklyn, New York, United States, 11215
        • Arthrosi Investigative Site (661)
      • Hartsdale, New York, United States, 10530
        • Arthrosi Investigative Site (663)
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Arthrosi Investigative Site (625)
      • Charlotte, North Carolina, United States, 28277
        • Arthrosi Investigative Site (681)
      • Raleigh, North Carolina, United States, 27607
        • Arthrosi Investigative Site (683)
      • Shelby, North Carolina, United States, 28150
        • Arthrosi Investigative Site (649)
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Arthrosi Investigative Site (666)
    • Ohio
      • Mason, Ohio, United States, 45040
        • Arthrosi Investigative Site (671)
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Arthrosi Investigative Site (631)
      • Tulsa, Oklahoma, United States, 74133
        • Arthrosi Investigative Site (642)
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • Arthrosi Investigative Site (647)
      • Philadelphia, Pennsylvania, United States, 19107
        • Arthrosi Investigative Site (623)
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Arthrosi Investigative Site (638)
      • Fort Mill, South Carolina, United States, 29707
        • Arthrosi Investigative Site (604)
      • North Charleston, South Carolina, United States, 29405
        • Arthrosi Investigative Site (608)
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Arthrosi Investigative Site (619)
      • Hendersonville, Tennessee, United States, 37075
        • Arthrosi Investigative Site (624)
    • Texas
      • Amarillo, Texas, United States, 79106
        • Arthrosi Investigative Site (670)
      • Austin, Texas, United States, 78735
        • Arthrosi Investigative Site (677)
      • DeSoto, Texas, United States, 75115
        • Arthrosi Investigative Site (639)
      • Houston, Texas, United States, 77074
        • Arthrosi Investigative Site (601)
      • Plano, Texas, United States, 75024
        • Arthrosi Investigative Site (688)
      • Prosper, Texas, United States, 75078
        • Arthrosi Investigative Site (689)
      • Tomball, Texas, United States, 77375
        • Arthrosi Investigative Site (646)
      • Tomball, Texas, United States, 77375
        • Arthrosi Investigative Site (659)
    • Utah
      • Clinton, Utah, United States, 84015
        • Arthrosi Investigative Site (643)
      • Salt Lake City, Utah, United States, 84121
        • Arthrosi Investigative Site (609)
      • Salt Lake City, Utah, United States, 84124
        • Arthrosi Investigative Site (654)
    • Washington
      • Bellevue, Washington, United States, 98004
        • Arthrosi Investigative Site (685)
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Arthrosi Investigative Site (668)

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)

March 11, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 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

  • AR882-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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