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GoutPhase 3NCT06846515

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

A Phase 3 study testing AR882 50 mg and AR882 75 mg in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 83 sites in United States.

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
866 participants
Where
83 sitesUnited States
Study dates
11 Mar 2025to 18 Sep 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

83 sites in 1 country.

83 sites in 1 country

United States83 sites

  • Arthrosi Investigative Site (670)

    Amarillo, Texas, 79106

  • Arthrosi Investigative Site (673)

    Atlanta, Georgia, 30329

  • Arthrosi Investigative Site (660)

    Aurora, Colorado, 80012

  • Arthrosi Investigative Site (677)

    Austin, Texas, 78735

  • Arthrosi Investigative Site (685)

    Bellevue, Washington, 98004

  • Arthrosi Investigative Site (620)

    Birmingham, Alabama, 35215

  • Arthrosi Investigative Site (676)

    Boise, Idaho, 83713

  • Arthrosi Investigative Site (661)

    Brooklyn, New York, 11215

  • Arthrosi Investigative Site (638)

    Charleston, South Carolina, 29407

  • Arthrosi Investigative Site (625)

    Charlotte, North Carolina, 28207

  • Arthrosi Investigative Site (681)

    Charlotte, North Carolina, 28277

  • Arthrosi Investigative Site (619)

    Chattanooga, Tennessee, 37404

  • Arthrosi Investigative Site (657)

    Chicago, Illinois, 60602

  • Arthrosi Investigative Site (643)

    Clinton, Utah, 84015

  • Arthrosi Investigative Site (669)

    Colorado Springs, Colorado, 80909

  • Arthrosi Investigative Site (665)

    Cooper City, Florida, 33024

  • Arthrosi Investigative Site (639)

    DeSoto, Texas, 75115

  • Arthrosi Investigative Site (636)

    Fall River, Massachusetts, 02721

  • Arthrosi Investigative Site (666)

    Fargo, North Dakota, 58104

  • Arthrosi Investigative Site (628)

    Farmington Hills, Michigan, 48334

  • Arthrosi Investigative Site (612)

    Fort Collins, Colorado, 80528

  • Arthrosi Investigative Site (604)

    Fort Mill, South Carolina, 29707

  • Arthrosi Investigative Site (614)

    Garden Grove, California, 92844

  • Arthrosi Investigative Site (633)

    Gulfport, Mississippi, 39503

  • Arthrosi Investigative Site (663)

    Hartsdale, New York, 10530

  • Arthrosi Investigative Site (624)

    Hendersonville, Tennessee, 37075

  • Arthrosi Investigative Site (658)

    Honolulu, Hawaii, 96814

  • Arthrosi Investigative Site (647)

    Horsham, Pennsylvania, 19044

  • Arthrosi Investigative Site (601)

    Houston, Texas, 77074

  • Arthrosi Investigative Site (616)

    Huntsville, Alabama, 35801

  • Arthrosi Investigative Site (678)

    Indianapolis, Indiana, 46202

  • Arthrosi Investigative Site (635)

    Jackson, Mississippi, 39202

  • Arthrosi Investigative Site (613)

    Jupiter, Florida, 33458

  • Arthrosi Investigative Site (668)

    Kenosha, Wisconsin, 53144

  • Arthrosi Investigative Site (618)

    La Mesa, California, 91942

  • Arthrosi Investigative Site (687)

    La Mesa, California, 91942

  • Arthrosi Investigative Site (655)

    La Palma, California, 90623

  • Arthrosi Investigative Site (686)

    Las Vegas, Nevada, 89102

  • Arthrosi Investigative Site (632)

    Lincoln, California, 95648

  • Arthrosi Investigative Site (610)

    Lincoln, Nebraska, 68516

  • Arthrosi Investigative Site (617)

    Little Rock, Arkansas, 72205

  • Arthrosi Investigative Site (605)

    Lomita, California, 90717

  • Arthrosi Investigative Site (675)

    Long Beach, California, 90806

  • Arthrosi Investigative Site (674)

    Louisville, Kentucky, 40205

  • Arthrosi Investigative Site (627)

    Mandeville, Louisiana, 70471

  • Arthrosi Investigative Site (652)

    Marietta, Georgia, 30060

  • Arthrosi Investigative Site (671)

    Mason, Ohio, 45040

  • Arthrosi Investigative Site (648)

    Melrose Park, Illinois, 60160

  • Arthrosi Investigative Site (634)

    Meridian, Idaho, 83642

  • Arthrosi Investigative Site (611)

    Miami, Florida, 33173

  • Arthrosi Investigative Site (644)

    Miami, Florida, 33176

  • Arthrosi Investigative Site (664)

    Missoula, Montana, 59808

  • Arthrosi Investigative Site (650)

    New Orleans, Louisiana, 70115

  • Arthrosi Investigative Site (631)

    Norman, Oklahoma, 73072

  • Arthrosi Investigative Site (608)

    North Charleston, South Carolina, 29405

  • Arthrosi Investigative Site (693)

    Olive Branch, Mississippi, 38654

  • Arthrosi Investigative Site (684)

    Omaha, Nebraska, 68114

  • Arthrosi Investigative Site (651)

    Omaha, Nebraska, 68144

  • Arthrosi Investigative Site (679)

    Overland Park, Kansas, 66209

  • Arthrosi Investigative Site (662)

    Oxon Hill, Maryland, 20745

  • Arthrosi Investigative Site (694)

    Palmetto Bay, Florida, 33157

  • Arthrosi Investigative Site (680)

    Peoria, Arizona, 85381

  • Arthrosi Investigative Site (623)

    Philadelphia, Pennsylvania, 19107

  • Arthrosi Investigative Site (640)

    Phoenix, Arizona, 85018

  • Arthrosi Investigative Site (688)

    Plano, Texas, 75024

  • Arthrosi Investigative Site (641)

    Prairieville, Louisiana, 70769

  • Arthrosi Investigative Site (689)

    Prosper, Texas, 75078

  • Arthrosi Investigative Site (683)

    Raleigh, North Carolina, 27607

  • Arthrosi Investigative Site (653)

    Rockville, Maryland, 20852

  • Arthrosi Investigative Site (609)

    Salt Lake City, Utah, 84121

  • Arthrosi Investigative Site (654)

    Salt Lake City, Utah, 84124

  • Arthrosi Investigative Site (615)

    Sanford, Florida, 32771

  • Arthrosi Investigative Site (603)

    Santa Monica, California, 90404

  • Arthrosi Investigative Site (649)

    Shelby, North Carolina, 28150

  • Arthrosi Investigative Site (645)

    Southfield, Michigan, 48076

  • Arthrosi Investigative Site (637)

    Springfield, Missouri, 65807

  • Arthrosi Investigative Site (600)

    Tampa, Florida, 33609

  • Arthrosi Investigative Site (672)

    Tarzana, California, 91356

  • Arthrosi Investigative Site (656)

    Thousand Oaks, California, 91360

  • Arthrosi Investigative Site (646)

    Tomball, Texas, 77375

  • Arthrosi Investigative Site (659)

    Tomball, Texas, 77375

  • Arthrosi Investigative Site (626)

    Town and Country, Missouri, 63017

  • Arthrosi Investigative Site (642)

    Tulsa, Oklahoma, 74133

Other trials in United States

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

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 NCT06846515
Study groupRoleWhat they receive
AR882 50 mgExperimentalAR882 50 mg taken once daily for 12 months
Receives: Drug: AR882 50 mg
AR882 75 mgExperimentalAR882 75 mg taken once daily for 12 months
Receives: Drug: AR882 75 mg
PlaceboPlacebo comparatorAR882 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted26 Feb 2025
  2. Study start11 Mar 2025
  3. Primary completion31 Aug 2026
  4. Study completion18 Sep 2026

Resources

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
866 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846515
Sponsor's protocol ID
AR882-301
Status last verified
Sep 2026
First submitted
21 Feb 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 83 sites in United States.

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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States. 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 NCT06846515.

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 28 Sep 2026.

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