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

August 27, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
818

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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, New Zealand, 0632
        • Arthrosi Investigative Site (302)
      • Auckland, New Zealand, 1010
        • Arthrosi Investigative Site (300)
      • Hamilton, New Zealand, 3200
        • Arthrosi Investigative Site (304)
      • Nelson, New Zealand, 7011
        • Arthrosi Investigative Site (303)
      • Rotorua, New Zealand, 3010
        • Arthrosi Investigative Site (301)
  • Taiwan
      • Kaohsiung City, Taiwan, 813
        • Arthrosi Investigative Site (406)
      • Kaohsiung City, Taiwan, 833
        • Arthrosi Investigative Site (404)
      • Taichung, Taiwan, 402
        • Arthrosi Investigative Site (402)
      • Taipei, Taiwan, 11217
        • Arthrosi Investigative Site (400)
      • Taipei, Taiwan, 112
        • Arthrosi Investigative Site (403)
      • Taoyuan City, Taiwan, 333
        • Arthrosi Investigative Site (401)
    • Taiwan
      • Hualien City, Taiwan, Taiwan, 97002
        • Arthrosi Investigative Site (405)
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Change in tophus burden by month 6
Time Frame: 24 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 6, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 6 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method
24 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arthrosi Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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