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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07116746

Enrollment

Registered

2025-08-12

Start date

2025-12-03

Completion date

2027-02-01

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Uricase Failure, Pegloticase Failure, Krystexxa Failure, Rasburicase Failure

Brief 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.

Interventions

DRUGAR882 75 mg

Solid Oral Capsule

DRUGXOI Low Dose

Solid Oral Tablet

DRUGXOI High Dose

Solid Oral Tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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 CLcr ≥ 40 mL/min

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6	24 weeks	Proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6

Secondary

Measure	Time frame	Description
Change in tophus burden by month 6	24 weeks	Change in tophus burden by measurement of targeted tophi area at Month 6
Incidence of Adverse Events	56 weeks	Treatment Emergent Adverse Events and Serious Adverse Event incidence

Countries

United States

Contacts

STUDY_DIRECTORRobert Keenan, MD

Arthrosi Therapeutics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026