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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07116746
- Acronym / sponsor ID
- AR882-204
- Conditions
- Gout, Gouty Arthritis, Hyperuricemia, Gout Chronic, Refractory Gout, Uncontrolled Gout
- Keywords
- Uricase Failure, Pegloticase Failure, Krystexxa Failure, Rasburicase Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AR882 75 mg + XOI | Experimental | Drug: AR882 75 mg, Drug: XOI Low Dose, Drug: XOI High DoseAR882 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR882 75 mgSolid Oral Capsule | Drug | AR882 75 mg + XOI |
| XOI Low DoseSolid Oral Tablet | Drug | AR882 75 mg + XOI |
| XOI High DoseSolid Oral Tablet | Drug | AR882 75 mg + XOI |
Primary outcome
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Time frame: 24 weeks
Proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
2 secondary outcomes
Change in tophus burden by month 6
Time frame: 24 weeks
Incidence of Adverse Events
Time frame: 56 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Keenan, MD study director
Arthrosi Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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 15 May 2026.