GoutPhase 3NCT06439602

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

A Phase 3 study testing AR882 50 mg and AR882 75 mg in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 68 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Gout, Arthritis, Gouty, Hyperuricemia
What is being tested?: AR882 50 mg and AR882 75 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 818 participants
Where: 68 sitesin 5 countries
Study dates: 26 Jun 2024to 10 Apr 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

68 sites in 5 countries.

Country

City, postcode or hospital

68 sites in 5 countries

United States52 sites

Arthrosi Investigative Site (110)
Amarillo, Texas, 79106
Arthrosi Investigative Site (139)
Anchorage, Alaska, 99508
Arthrosi Investigative Site (121)
Ann Arbor, Michigan, 48109
Arthrosi Investigative Site (164)
Atlanta, Georgia, 30329
Arthrosi Investigative Site (101)
Aurora, Colorado, 80014
Arthrosi Investigative Site (133)
Boise, Idaho, 83713
Arthrosi Investigative Site (142)
Bountiful, Utah, 98021
Arthrosi Investigative Site (158)
Brooklyn, New York, 11215
Arthrosi Investigative Site (149)
Clearwater, Florida, 33756
Arthrosi Investigative Site (148)
Cleveland, Ohio, 44195
Arthrosi Investigative Site (115)
Coral Gables, Florida, 33134
Arthrosi Investigative Site (104)
Dallas, Texas, 75251
Arthrosi Investigative Site (146)
Dayton, Ohio, 45429
Arthrosi Investigative Site (128)
DeLand, Florida, 32720
Arthrosi Investigative Site (105)
Detroit, Michigan, 48076
Arthrosi Investigative Site (131)
El Cajon, California, 92108
Arthrosi Investigative Site (117)
Encinitas, California, 92024
Arthrosi Investigative Site (106)
Foley, Alabama, 36535
Arthrosi Investigative Site (116)
Graham, Texas, 76450
Arthrosi Investigative Site (137)
Greensboro, North Carolina, 27410
Arthrosi Investigative Site (150)
Hagerstown, Maryland, 21740
Arthrosi Investigative Site (111)
Hampton, Virginia, 23666
Arthrosi Investigative Site (118)
Hampton, Virginia, 23666
Arthrosi Investigative Site (120)
Hatboro, Pennsylvania, 19040
Arthrosi Investigative Site (102)
Hollywood, Florida, 33024
Arthrosi Investigative Site (119)
Kansas City, Missouri, 64151
Arthrosi Investigative Site (126)
Lake Jackson, Texas, 77566
Arthrosi Investigative Site (162)
Lilburn, Georgia, 30047
Arthrosi Investigative Site (156)
Maitland, Florida, 32751
Arthrosi Investigative Site (103)
Miami, Florida, 33176
Arthrosi Investigative Site (136)
Missouri City, Texas, 77459
Arthrosi Investigative Site (147)
Myrtle Beach, South Carolina, 29572
Arthrosi Investigative Site (144)
New Orleans, Louisiana, 70115
Arthrosi Investigative Site (145)
Ogden, Utah, 84405
Arthrosi Investigative Site (153)
Olive Branch, Mississippi, 38654-3514
Arthrosi Investigative Site (157)
Palmetto Bay, Florida, 91355
Arthrosi Investigative Site (160)
Peoria, Arizona, 85381
Arthrosi Investigative Site (112)
Phoenix, Arizona, 85037
Arthrosi Investigative Site (129)
Plano, Texas, 75024
Arthrosi Investigative Site (138)
Rancho Cucamonga, California, 91730
Arthrosi Investigative Site (132)
Rapid City, South Dakota, 57702
Arthrosi Investigative Site (122)
River Forest, Illinois, 48109
Arthrosi Investigative Site (127)
Round Rock, Texas, 78681
Arthrosi Investigative Site (140)
Shelby, North Carolina, 28150
Arthrosi Investigative Site (114)
Tempe, Arizona, 85281
Arthrosi Investigative Site (107)
Tomball, Texas, 77375
Arthrosi Investigative Site (124)
Tomball, Texas, 77377
Arthrosi Investigative Site (161)
Valencia, California, 28277
Arthrosi Investigative Site (154)
Wichita, Kansas, 67207
Arthrosi Investigative Site (130)
Wilmington, North Carolina, 28403
Arthrosi Investigative Site (134)
Winchester, Virginia, 22601
Arthrosi Investigative Site (151)
Winter Haven, Florida, 33880

Other trials in United States

Taiwan7 sites

Arthrosi Investigative Site (405)
Hualien City, Taiwan, 97002
Arthrosi Investigative Site (404)
Kaohsiung City, Taiwan, 833
Arthrosi Investigative Site (406)
Kaohsiung City, 813
Arthrosi Investigative Site (402)
Taichung, 402
Arthrosi Investigative Site (400)
Taipei, Taiwan, 11217
Arthrosi Investigative Site (403)
Taipei, Taiwan, 112
Arthrosi Investigative Site (401)
Taoyuan City, Taiwan, 333

Other trials in Taiwan

New Zealand5 sites

Arthrosi Investigative Site (300)
Auckland, Auckland, 1010
Arthrosi Investigative Site (302)
Auckland, New Zealand, 0632
Arthrosi Investigative Site (304)
Hamilton, Hamilton, 3200
Arthrosi Investigative Site (303)
Nelson, New Zealand, 7011
Arthrosi Investigative Site (301)
Rotorua, New Zealand, 3010

Other trials in New Zealand

Australia2 sites

Arthrosi Investigative Site (202)
Botany, New South Wales, 2019
Arthrosi Investigative Site (200)
Camberwell, Victoria, 3124

Other trials in Australia

Hong Kong2 sites

Arthrosi Investigative Site (500)
Hong Kong, Central
Arthrosi Investigative Site (501)
Hong Kong, Hong Kong Island

Other trials in Hong Kong

About this study

Official title: 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

Conditions: Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
Being tested: AR882 50 mg, AR882 75 mg, Placebo
Medical subject headings: Gout, Arthritis, Gouty, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AR882 50 mgDrug
Solid Oral Capsule
AR882 75 mgDrug
Solid Oral Capsule
PlaceboDrug
Matching Solid Oral Capsule Placebo

Study groups in NCT06439602
Study group	Role	What they receive
AR882 50 mg	Experimental	AR882 50 mg taken once daily for 12 months Receives: Drug: AR882 50 mg
AR882 75 mg	Experimental	AR882 75 mg taken once daily for 12 months Receives: Drug: AR882 75 mg
Placebo	Placebo comparator	AR882 matching placebo taken once daily for 12 months Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Change in tophus burden by month 12
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
Measured: 48 weeks
Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12
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
Measured: 12 weeks
Change in tophus burden by month 6
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
Measured: 24 weeks
Incidence of Adverse Events
Treatment Emergent Adverse Events and Serious Adverse Event incidence
Measured: 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202410 Apr 2026

First posted3 Jun 2024
Study start26 Jun 2024
Primary completion20 Mar 2026
Study completion10 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GoutStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 818 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06439602
Sponsor's protocol ID: AR882-302
Status last verified: Aug 2026
First submitted: 28 May 2024
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
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RecruitingPhase 3
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Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
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The Remote Monitoring of Gout Study
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All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout
ClinicalTrials.gov ID: NCT06439602
Acronym / sponsor ID: AR882-302
Conditions: Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 818 participants (actual)
Lead sponsor: Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
Study start: 26 Jun 2024 (actual)
Primary completion: 20 Mar 2026 (actual)
Study completion: 10 Apr 2026 (actual)
First posted: 3 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AR882 50 mg	Experimental	Drug: AR882 50 mgAR882 50 mg taken once daily for 12 months
AR882 75 mg	Experimental	Drug: AR882 75 mgAR882 75 mg taken once daily for 12 months
Placebo	Placebo comparator	Drug: PlaceboAR882 matching placebo taken once daily for 12 months

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AR882 50 mgSolid Oral Capsule	Drug	AR882 50 mg
AR882 75 mgSolid Oral Capsule	Drug	AR882 75 mg
PlaceboMatching Solid Oral Capsule Placebo	Drug	Placebo

Primary outcome

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

4 secondary outcomes

Change in tophus burden by month 12
Time frame: 48 weeks
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
Change in tophus burden by month 6
Time frame: 24 weeks
Incidence of Adverse Events
Time frame: 56 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.

Related trials for Gout

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Keenan, MD study director

Arthrosi Therapeutics, Inc.

68 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AR882 50 mg and AR882 75 mg in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 68 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Taiwan, New Zealand, Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06439602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.