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NCT07116746 | RECRUITING | Gout

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

Arthrosi Therapeutics

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.

Condition or disease

Gout

Gouty Arthritis

Hyperuricemia

Gout Chronic

Refractory Gout

Uncontrolled Gout

Tophaceous Gout

Intervention/treatment

AR882 75 mg

XOI Low Dose

XOI High Dose

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-12-03
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

Location Details

NCT07116746

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Arthrosi Investigative Site (105)

Margate, florida, United States, 33063

RECRUITING

United States, Florida

Arthrosi Investigative Site (102)

Miami, florida, United States, 33155

RECRUITING

United States, Florida

Arthrosi Investigative Site (109)

Tampa, florida, United States, 33609

RECRUITING

United States, Mississippi

Arthrosi Investigative Site (106)

Jackson, Mississippi, United States, 39202

RECRUITING

United States, North Carolina

Arthrosi Investigative Site (108)

Charlotte, North Carolina, United States, 28202

RECRUITING

United States, Pennsylvania

Arthrosi Investigative Site (103)

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Texas

Arthrosi Investigative Site (104)

West Lake Hills, Texas, United States, 78746

RECRUITING

United States, Washington

Arthrosi Investigative Site (107)

Bellevue, Washington, United States, 98004