NCT07116746

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
8mo left

Started Dec 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Dec 2025Feb 2027

First Submitted

Initial submission to the registry

August 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

August 7, 2025

Last Update Submit

May 13, 2026

Conditions

GoutGouty ArthritisHyperuricemiaGout ChronicRefractory GoutTophaceous GoutUncontrolled Gout

Keywords

Uricase FailurePegloticase FailureKrystexxa FailureRasburicase Failure

Outcome Measures

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

    24 weeks

Secondary Outcomes (2)

  • Change in tophus burden by month 6

    24 weeks

  • Incidence of Adverse Events

    56 weeks

Study Arms (1)

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.

Drug: AR882 75 mgDrug: XOI Low DoseDrug: XOI High Dose

Interventions

AR882 75 mgDRUG

Solid Oral Capsule

AR882 75 mg + XOI
XOI Low DoseDRUG

Solid Oral Tablet

AR882 75 mg + XOI
XOI High DoseDRUG

Solid Oral Tablet

AR882 75 mg + XOI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Arthrosi Investigative Site (105)

Margate, Florida, 33063, United States

Location

Arthrosi Investigative Site (102)

Miami, Florida, 33155, United States

Location

Arthrosi Investigative Site (109)

Tampa, Florida, 33609, United States

Location

Arthrosi Investigative Site (106)

Jackson, Mississippi, 39202, United States

Location

Arthrosi Investigative Site (108)

Charlotte, North Carolina, 28202, United States

Location

Arthrosi Investigative Site (103)

Duncansville, Pennsylvania, 16635, United States

Location

Arthrosi Investigative Site (104)

West Lake Hills, Texas, 78746, United States

Location

Arthrosi Investigative Site (107)

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

GoutArthritis, GoutyHyperuricemia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Keenan, MD

    Arthrosi Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 12, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(8)