ClinicalTrials.gg
CompletedNCT06439602Updated Oct 14, 2026

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

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 68 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

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 Oct 14, 20269 sites added9 sites removedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
818
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 818 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
818 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

68 sites
  • Arthrosi Investigative Site (106)
    Foley, Alabama 36535, United States
  • Arthrosi Investigative Site (139)
    Anchorage, Alaska 99508, United States
  • Arthrosi Investigative Site (160)
    Peoria, Arizona 85381, United States
  • Arthrosi Investigative Site (112)
    Phoenix, Arizona 85037, United States
  • Arthrosi Investigative Site (114)
    Tempe, Arizona 85281, United States
  • Arthrosi Investigative Site (131)
    El Cajon, California 92108, United States
  • Arthrosi Investigative Site (117)
    Encinitas, California 92024, United States
  • Arthrosi Investigative Site (138)
    Rancho Cucamonga, California 91730, United States
  • Arthrosi Investigative Site (161)
    Valencia, California 28277, United States
  • Arthrosi Investigative Site (101)
    Aurora, Colorado 80014, United States
  • Arthrosi Investigative Site (149)
    Clearwater, Florida 33756, United States
  • Arthrosi Investigative Site (115)
    Coral Gables, Florida 33134, United States
  • Arthrosi Investigative Site (128)
    DeLand, Florida 32720, United States
  • Arthrosi Investigative Site (102)
    Hollywood, Florida 33024, United States
  • Arthrosi Investigative Site (156)
    Maitland, Florida 32751, United States
  • Arthrosi Investigative Site (103)
    Miami, Florida 33176, United States
  • Arthrosi Investigative Site (157)
    Palmetto Bay, Florida 91355, United States
  • Arthrosi Investigative Site (151)
    Winter Haven, Florida 33880, United States
  • Arthrosi Investigative Site (164)
    Atlanta, Georgia 30329, United States
  • Arthrosi Investigative Site (162)
    Lilburn, Georgia 30047, United States
  • Arthrosi Investigative Site (133)
    Boise, Idaho 83713, United States
  • Arthrosi Investigative Site (122)
    River Forest, Illinois 48109, United States
  • Arthrosi Investigative Site (154)
    Wichita, Kansas 67207, United States
  • Arthrosi Investigative Site (144)
    New Orleans, Louisiana 70115, United States
  • Arthrosi Investigative Site (150)
    Hagerstown, Maryland 21740, United States
  • Arthrosi Investigative Site (121)
    Ann Arbor, Michigan 48109, United States
  • Arthrosi Investigative Site (105)
    Detroit, Michigan 48076, United States
  • Arthrosi Investigative Site (153)
    Olive Branch, Mississippi 38654-3514, United States
  • Arthrosi Investigative Site (119)
    Kansas City, Missouri 64151, United States
  • Arthrosi Investigative Site (158)
    Brooklyn, New York 11215, United States
  • Arthrosi Investigative Site (137)
    Greensboro, North Carolina 27410, United States
  • Arthrosi Investigative Site (140)
    Shelby, North Carolina 28150, United States
  • Arthrosi Investigative Site (130)
    Wilmington, North Carolina 28403, United States
  • Arthrosi Investigative Site (148)
    Cleveland, Ohio 44195, United States
  • Arthrosi Investigative Site (146)
    Dayton, Ohio 45429, United States
  • Arthrosi Investigative Site (120)
    Hatboro, Pennsylvania 19040, United States
  • Arthrosi Investigative Site (147)
    Myrtle Beach, South Carolina 29572, United States
  • Arthrosi Investigative Site (132)
    Rapid City, South Dakota 57702, United States
  • Arthrosi Investigative Site (110)
    Amarillo, Texas 79106, United States
  • Arthrosi Investigative Site (104)
    Dallas, Texas 75251, United States
  • Arthrosi Investigative Site (116)
    Graham, Texas 76450, United States
  • Arthrosi Investigative Site (126)
    Lake Jackson, Texas 77566, United States
  • Arthrosi Investigative Site (136)
    Missouri City, Texas 77459, United States
  • Arthrosi Investigative Site (129)
    Plano, Texas 75024, United States
  • Arthrosi Investigative Site (127)
    Round Rock, Texas 78681, United States
  • Arthrosi Investigative Site (107)
    Tomball, Texas 77375, United States
  • Arthrosi Investigative Site (124)
    Tomball, Texas 77377, United States
  • Arthrosi Investigative Site (142)
    Bountiful, Utah 98021, United States
  • Arthrosi Investigative Site (145)
    Ogden, Utah 84405, United States
  • Arthrosi Investigative Site (111)
    Hampton, Virginia 23666, United States
  • Arthrosi Investigative Site (118)
    Hampton, Virginia 23666, United States
  • Arthrosi Investigative Site (134)
    Winchester, Virginia 22601, United States
  • Arthrosi Investigative Site (202)
    Botany, New South Wales 2019, Australia
  • Arthrosi Investigative Site (200)
    Camberwell, Victoria 3124, Australia
  • Arthrosi Investigative Site (500)
    Hong Kong, Central, Hong Kong
  • Arthrosi Investigative Site (501)
    Hong Kong, Hong Kong Island, Hong Kong
  • Arthrosi Investigative Site (300)
    Auckland, Auckland 1010, New Zealand
  • Arthrosi Investigative Site (304)
    Hamilton, Hamilton 3200, New Zealand
  • Arthrosi Investigative Site (302)
    Auckland, New Zealand 0632, New Zealand
  • Arthrosi Investigative Site (303)
    Nelson, New Zealand 7011, New Zealand
  • Arthrosi Investigative Site (301)
    Rotorua, New Zealand 3010, New Zealand
  • Arthrosi Investigative Site (405)
    Hualien City, Taiwan 97002, Taiwan
  • Arthrosi Investigative Site (404)
    Kaohsiung City, Taiwan 833, Taiwan
  • Arthrosi Investigative Site (400)
    Taipei, Taiwan 11217, Taiwan
  • Arthrosi Investigative Site (403)
    Taipei, Taiwan 112, Taiwan
  • Arthrosi Investigative Site (401)
    Taoyuan City, Taiwan 333, Taiwan
  • Arthrosi Investigative Site (406)
    Kaohsiung City, 813, Taiwan
  • Arthrosi Investigative Site (402)
    Taichung, 402, Taiwan
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2024 to primary completion in Mar 2026, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2024
First posted
Jun 3, 2024
StartActual
Jun 26, 2024
Primary completionActual
Mar 20, 2026
CompletionActual
Apr 10, 2026
Results delay requested
Oct 9, 2026
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
9 sites added, 9 sites removed
Show 9 added (5 New Zealand, 4 Taiwan)
  • Arthrosi Investigative Site (300) · Auckland, New Zealand
  • Arthrosi Investigative Site (304) · Hamilton, New Zealand
  • Arthrosi Investigative Site (302) · Auckland, New Zealand
  • Arthrosi Investigative Site (303) · Nelson, New Zealand
  • Arthrosi Investigative Site (301) · Rotorua, New Zealand
  • Arthrosi Investigative Site (404) · Kaohsiung City, Taiwan
  • Arthrosi Investigative Site (400) · Taipei, Taiwan
  • Arthrosi Investigative Site (403) · Taipei, Taiwan
  • Arthrosi Investigative Site (401) · Taoyuan City, Taiwan
Show 9 removed
  • Arthrosi Investigative Site (302) · Auckland, New Zealand
  • Arthrosi Investigative Site (300) · Auckland, New Zealand
  • Arthrosi Investigative Site (304) · Hamilton, New Zealand
  • Arthrosi Investigative Site (303) · Nelson, New Zealand
  • Arthrosi Investigative Site (301) · Rotorua, New Zealand
  • Arthrosi Investigative Site (404) · Kaohsiung City, Taiwan
  • Arthrosi Investigative Site (400) · Taipei, Taiwan
  • Arthrosi Investigative Site (403) · Taipei, Taiwan
  • Arthrosi Investigative Site (401) · Taoyuan City, Taiwan
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    9 sites added, 9 sites removed
    Show 9 added (5 New Zealand, 4 Taiwan)
    • Arthrosi Investigative Site (300) · Auckland, New Zealand
    • Arthrosi Investigative Site (304) · Hamilton, New Zealand
    • Arthrosi Investigative Site (302) · Auckland, New Zealand
    • Arthrosi Investigative Site (303) · Nelson, New Zealand
    • Arthrosi Investigative Site (301) · Rotorua, New Zealand
    • Arthrosi Investigative Site (404) · Kaohsiung City, Taiwan
    • Arthrosi Investigative Site (400) · Taipei, Taiwan
    • Arthrosi Investigative Site (403) · Taipei, Taiwan
    • Arthrosi Investigative Site (401) · Taoyuan City, Taiwan
    Show 9 removed
    • Arthrosi Investigative Site (302) · Auckland, New Zealand
    • Arthrosi Investigative Site (300) · Auckland, New Zealand
    • Arthrosi Investigative Site (304) · Hamilton, New Zealand
    • Arthrosi Investigative Site (303) · Nelson, New Zealand
    • Arthrosi Investigative Site (301) · Rotorua, New Zealand
    • Arthrosi Investigative Site (404) · Kaohsiung City, Taiwan
    • Arthrosi Investigative Site (400) · Taipei, Taiwan
    • Arthrosi Investigative Site (403) · Taipei, Taiwan
    • Arthrosi Investigative Site (401) · Taoyuan City, Taiwan
    + 1 other change: registry dates

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 ↗

09

Registry details

Key details

Study ID
NCT06439602
Responsible party
Sponsor
First posted
Jun 3, 2024
Start date
Jun 26, 2024
Primary completion
Mar 20, 2026
Completion
Apr 10, 2026
Last update
Oct 14, 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

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Studies of the drug tested here: AR882

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