ClinicalTrials.gg
CompletedNCT06846515Updated Sep 28, 2026

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

A Phase 3 interventional study of AR882 50 mg and AR882 75 mg in Gout, Arthritis, Gouty and Hyperuricemia, sponsored by Arthrosi Therapeutics. Completed at 83 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Primary conditionArthritis, GoutyRegistry: GoutReclassifiedWhy we changed it
Registry
Gout — the first condition term the registry derived for this study.
ClinicalTrials.gg
Arthritis, Gouty
Why
  1. The study's listed conditions name Arthritis, Gouty, a narrower term within Gout.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Arthrosi Therapeutics (part of Swedish Orphan Biovitrum) · Phase 3, Interventional, and Treatment

Updated Sep 28, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
866
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Gout
  • Arthritis, Gouty
  • Hyperuricemia
  • Gout Chronic

Browse trials for

03

In context

Arthritis, Gouty Reclassified

47 studies on the registry are indexed under Arthritis, Gouty; 16 are open to participants now.

This study's enrollment of 866 is above the median of 140 across 35 interventional studies indexed under Arthritis, Gouty.

Browse Arthritis, Gouty studies →

Lead sponsor

Arthrosi Therapeutics is the lead sponsor of 10 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

First submitted before Arthrosi Therapeutics became part of Swedish Orphan Biovitrum.

Compared within Arthritis, Gouty, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gout. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ≥ 30 mL/min

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
866 participants (actual)

Study arms

  • Experimental
    AR882 50 mg

    AR882 50 mg taken once daily for 12 months

    Drug: AR882 50 mg

  • Experimental
    AR882 75 mg

    AR882 75 mg taken once daily for 12 months

    Drug: AR882 75 mg

  • Placebo comparator
    Placebo

    AR882 matching placebo taken once daily for 12 months

    Drug: Placebo

Interventions

  • Solid Oral Capsule

  • Solid Oral Capsule

  • DrugPlacebo

    Matching Solid Oral Capsule Placebo

06

What researchers measure

Primary outcomes

  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

    Time frame: 24 weeks

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 24 weeks

  4. Incidence of Adverse Events

    Treatment Emergent Adverse Events and Serious Adverse Event incidence

    Time frame: 56 weeks

07

Study locations

83 sites
  • Arthrosi Investigative Site (620)
    Birmingham, Alabama 35215, United States
  • Arthrosi Investigative Site (616)
    Huntsville, Alabama 35801, United States
  • Arthrosi Investigative Site (680)
    Peoria, Arizona 85381, United States
  • Arthrosi Investigative Site (640)
    Phoenix, Arizona 85018, United States
  • Arthrosi Investigative Site (617)
    Little Rock, Arkansas 72205, United States
  • Arthrosi Investigative Site (614)
    Garden Grove, California 92844, United States
  • Arthrosi Investigative Site (618)
    La Mesa, California 91942, United States
  • Arthrosi Investigative Site (687)
    La Mesa, California 91942, United States
  • Arthrosi Investigative Site (655)
    La Palma, California 90623, United States
  • Arthrosi Investigative Site (632)
    Lincoln, California 95648, United States
  • Arthrosi Investigative Site (605)
    Lomita, California 90717, United States
  • Arthrosi Investigative Site (675)
    Long Beach, California 90806, United States
  • Arthrosi Investigative Site (603)
    Santa Monica, California 90404, United States
  • Arthrosi Investigative Site (672)
    Tarzana, California 91356, United States
  • Arthrosi Investigative Site (656)
    Thousand Oaks, California 91360, United States
  • Arthrosi Investigative Site (660)
    Aurora, Colorado 80012, United States
  • Arthrosi Investigative Site (669)
    Colorado Springs, Colorado 80909, United States
  • Arthrosi Investigative Site (612)
    Fort Collins, Colorado 80528, United States
  • Arthrosi Investigative Site (665)
    Cooper City, Florida 33024, United States
  • Arthrosi Investigative Site (613)
    Jupiter, Florida 33458, United States
  • Arthrosi Investigative Site (611)
    Miami, Florida 33173, United States
  • Arthrosi Investigative Site (644)
    Miami, Florida 33176, United States
  • Arthrosi Investigative Site (694)
    Palmetto Bay, Florida 33157, United States
  • Arthrosi Investigative Site (615)
    Sanford, Florida 32771, United States
  • Arthrosi Investigative Site (600)
    Tampa, Florida 33609, United States
  • Arthrosi Investigative Site (673)
    Atlanta, Georgia 30329, United States
  • Arthrosi Investigative Site (652)
    Marietta, Georgia 30060, United States
  • Arthrosi Investigative Site (658)
    Honolulu, Hawaii 96814, United States
  • Arthrosi Investigative Site (676)
    Boise, Idaho 83713, United States
  • Arthrosi Investigative Site (634)
    Meridian, Idaho 83642, United States
  • Arthrosi Investigative Site (657)
    Chicago, Illinois 60602, United States
  • Arthrosi Investigative Site (648)
    Melrose Park, Illinois 60160, United States
  • Arthrosi Investigative Site (678)
    Indianapolis, Indiana 46202, United States
  • Arthrosi Investigative Site (679)
    Overland Park, Kansas 66209, United States
  • Arthrosi Investigative Site (674)
    Louisville, Kentucky 40205, United States
  • Arthrosi Investigative Site (627)
    Mandeville, Louisiana 70471, United States
  • Arthrosi Investigative Site (650)
    New Orleans, Louisiana 70115, United States
  • Arthrosi Investigative Site (641)
    Prairieville, Louisiana 70769, United States
  • Arthrosi Investigative Site (662)
    Oxon Hill, Maryland 20745, United States
  • Arthrosi Investigative Site (653)
    Rockville, Maryland 20852, United States
  • Arthrosi Investigative Site (636)
    Fall River, Massachusetts 02721, United States
  • Arthrosi Investigative Site (628)
    Farmington Hills, Michigan 48334, United States
  • Arthrosi Investigative Site (645)
    Southfield, Michigan 48076, United States
  • Arthrosi Investigative Site (633)
    Gulfport, Mississippi 39503, United States
  • Arthrosi Investigative Site (635)
    Jackson, Mississippi 39202, United States
  • Arthrosi Investigative Site (693)
    Olive Branch, Mississippi 38654, United States
  • Arthrosi Investigative Site (637)
    Springfield, Missouri 65807, United States
  • Arthrosi Investigative Site (626)
    Town and Country, Missouri 63017, United States
  • Arthrosi Investigative Site (664)
    Missoula, Montana 59808, United States
  • Arthrosi Investigative Site (610)
    Lincoln, Nebraska 68516, United States
  • Arthrosi Investigative Site (684)
    Omaha, Nebraska 68114, United States
  • Arthrosi Investigative Site (651)
    Omaha, Nebraska 68144, United States
  • Arthrosi Investigative Site (686)
    Las Vegas, Nevada 89102, United States
  • Arthrosi Investigative Site (661)
    Brooklyn, New York 11215, United States
  • Arthrosi Investigative Site (663)
    Hartsdale, New York 10530, United States
  • Arthrosi Investigative Site (625)
    Charlotte, North Carolina 28207, United States
  • Arthrosi Investigative Site (681)
    Charlotte, North Carolina 28277, United States
  • Arthrosi Investigative Site (683)
    Raleigh, North Carolina 27607, United States
  • Arthrosi Investigative Site (649)
    Shelby, North Carolina 28150, United States
  • Arthrosi Investigative Site (666)
    Fargo, North Dakota 58104, United States
  • Arthrosi Investigative Site (671)
    Mason, Ohio 45040, United States
  • Arthrosi Investigative Site (631)
    Norman, Oklahoma 73072, United States
  • Arthrosi Investigative Site (642)
    Tulsa, Oklahoma 74133, United States
  • Arthrosi Investigative Site (647)
    Horsham, Pennsylvania 19044, United States
  • Arthrosi Investigative Site (623)
    Philadelphia, Pennsylvania 19107, United States
  • Arthrosi Investigative Site (638)
    Charleston, South Carolina 29407, United States
  • Arthrosi Investigative Site (604)
    Fort Mill, South Carolina 29707, United States
  • Arthrosi Investigative Site (608)
    North Charleston, South Carolina 29405, United States
  • Arthrosi Investigative Site (619)
    Chattanooga, Tennessee 37404, United States
  • Arthrosi Investigative Site (624)
    Hendersonville, Tennessee 37075, United States
  • Arthrosi Investigative Site (670)
    Amarillo, Texas 79106, United States
  • Arthrosi Investigative Site (677)
    Austin, Texas 78735, United States
  • Arthrosi Investigative Site (639)
    DeSoto, Texas 75115, United States
  • Arthrosi Investigative Site (601)
    Houston, Texas 77074, United States
  • Arthrosi Investigative Site (688)
    Plano, Texas 75024, United States
  • Arthrosi Investigative Site (689)
    Prosper, Texas 75078, United States
  • Arthrosi Investigative Site (646)
    Tomball, Texas 77375, United States
  • Arthrosi Investigative Site (659)
    Tomball, Texas 77375, United States
  • Arthrosi Investigative Site (643)
    Clinton, Utah 84015, United States
  • Arthrosi Investigative Site (609)
    Salt Lake City, Utah 84121, United States
  • Arthrosi Investigative Site (654)
    Salt Lake City, Utah 84124, United States
  • Arthrosi Investigative Site (685)
    Bellevue, Washington 98004, United States
  • Arthrosi Investigative Site (668)
    Kenosha, Wisconsin 53144, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Sep 28, 2026
Primary completion
Sep 2026→Aug 31, 2026 (actual)
Sep 28, 2026
Study completion
Oct 2026→Sep 18, 2026 (actual)
Sep 28, 2026
Enrollment
750 (estimated)→866 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Active, not recruiting→Completed
    Primary completion Sep 2026→Aug 31, 2026 (now actual)
    Study completion Oct 2026→Sep 18, 2026 (now actual)
    Enrollment 750 (estimated)→866 (actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06846515
Responsible party
Sponsor
First posted
Feb 26, 2025
Start date
Mar 11, 2025
Primary completion
Aug 31, 2026
Completion
Sep 18, 2026
Last update
Sep 28, 2026

Study contacts

Robert Keenan, MD
study director · Arthrosi Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: AR882

Start the discussion