ClinicalTrials.gg
Active, not recruitingNCT07116746Updated May 15, 2026

Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

A Phase 2 interventional study of AR882 75 mg and XOI Low Dose in Gout, Gouty Arthritis and Hyperuricemia, sponsored by Arthrosi Therapeutics. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-15.

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 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.

02

Conditions studied

  • Gout
  • Gouty Arthritis
  • Hyperuricemia
  • Gout Chronic
  • Refractory Gout
  • Uncontrolled Gout
  • Tophaceous Gout

Browse trials for

Keywords

  • Uricase Failure
  • Pegloticase Failure
  • Krystexxa Failure
  • Rasburicase Failure
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 planned enrollment of 15 is below 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 uncontrolled gout
  • Presence of ≥1 clinically visible tophus
  • Last uricase infusion occurred ≥3 months
  • Body weight no less than 50 kg
  • Serum creatinine must be \< 3.0 mg/dL and estimated ≥ 40 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
  • Received pegloticase, rasburicase or other experimental uricases within the last 3 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    AR882 75 mg + XOI

    AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period.

    Drug: AR882 75 mg · Drug: XOI Low Dose · Drug: XOI High Dose

Interventions

  • Solid Oral Capsule

  • DrugXOI Low Dose

    Solid Oral Tablet

  • DrugXOI High Dose

    Solid Oral Tablet

06

What researchers measure

Primary outcomes

  1. Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

    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 6

    Change in tophus burden by measurement of targeted tophi area at Month 6

    Time frame: 24 weeks

  2. Incidence of Adverse Events

    Treatment Emergent Adverse Events and Serious Adverse Event incidence

    Time frame: 56 weeks

07

Study locations

8 sites
  • Arthrosi Investigative Site (105)
    Margate, Florida 33063, United States
  • Arthrosi Investigative Site (102)
    Miami, Florida 33155, United States
  • Arthrosi Investigative Site (109)
    Tampa, Florida 33609, United States
  • Arthrosi Investigative Site (106)
    Jackson, Mississippi 39202, United States
  • Arthrosi Investigative Site (108)
    Charlotte, North Carolina 28202, United States
  • Arthrosi Investigative Site (103)
    Duncansville, Pennsylvania 16635, United States
  • Arthrosi Investigative Site (104)
    West Lake Hills, Texas 78746, United States
  • Arthrosi Investigative Site (107)
    Bellevue, Washington 98004, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Nov 2026, 11 months after the start.

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

Registered
Aug 7, 2025
First posted
Aug 12, 2025
StartActual
Dec 3, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Feb 2027
Last update
May 15, 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.
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07116746
Responsible party
Sponsor
First posted
Aug 12, 2025
Start date
Dec 3, 2025
Primary completion
Nov 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
May 15, 2026

Study contacts

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

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: AR882

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