GoutPhase 2NCT07116746
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
A Phase 2 study testing AR882 75 mg, XOI Low Dose and XOI High Dose in people with Gout and Gouty Arthritis, run by Arthrosi Therapeutics at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gout, Gouty Arthritis, Hyperuricemia
- What is being tested?
- AR882 75 mg, XOI Low Dose and XOI High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Dec 2025to Feb 2027
- Phase
- Phase 2
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 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 CLcr ≥ 40 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
- Received pegloticase, rasburicase or other experimental uricases within the last 3 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Arthrosi Investigative Site (107)
Bellevue, Washington, 98004
Arthrosi Investigative Site (108)
Charlotte, North Carolina, 28202
Arthrosi Investigative Site (103)
Duncansville, Pennsylvania, 16635
Arthrosi Investigative Site (106)
Jackson, Mississippi, 39202
Arthrosi Investigative Site (105)
Margate, Florida, 33063
Arthrosi Investigative Site (102)
Miami, Florida, 33155
Arthrosi Investigative Site (109)
Tampa, Florida, 33609
Arthrosi Investigative Site (104)
West Lake Hills, Texas, 78746
About this study
Official title: A Phase 2, Multicenter, Open-label, Efficacy and Safety Study of AR882 and XOI Co-administration in Participants With Uncontrolled Gout Who Have Previously Failed Uricase Treatment
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.
- Conditions
- Gout, Gouty Arthritis, Hyperuricemia, Gout Chronic, Refractory Gout, Uncontrolled Gout
- Being tested
- AR882 75 mg, XOI Low Dose, XOI High Dose
- Keywords
- Uricase Failure, Pegloticase Failure, Krystexxa Failure, Rasburicase Failure
- 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 75 mgDrug
Solid Oral Capsule
XOI Low DoseDrug
Solid Oral Tablet
XOI High DoseDrug
Solid Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| AR882 75 mg + XOI | Experimental | 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. Receives: Drug: AR882 75 mg; Drug: XOI Low Dose; Drug: XOI High Dose |
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
Proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Measured: 24 weeks
Secondary outcomes (2)
Change in tophus burden by month 6
Change in tophus burden by measurement of targeted tophi area at Month 6
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.
- First posted12 Aug 2025
- Study start3 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Keenan, MD, Study director, Arthrosi Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116746
- Sponsor's protocol ID
- AR882-204
- Status last verified
- May 2026
- First submitted
- 7 Aug 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No