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Clinical Trials/NCT06439602
NCT06439602CompletedPhase 3

A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout

Arthrosi Therapeutics134 sites in 1 country818 target enrollmentStarted: June 26, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
818
Locations
134
Primary Endpoint
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •History of gout
  • •Occurrence of ≥ 2 self-reported gout flares in the last 12 months
  • •Body weight no less than 50 kg
  • •Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
  • •Patients who are on medically appropriate ULT must have sUA > 6 mg/dL
  • •Serum creatinine must be < 3.0 mg/dL and estimated CLcr ≥ 30 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

Arms & Interventions

AR882 75 mg

Experimental

AR882 75 mg taken once daily for 12 months

Intervention: AR882 75 mg (Drug)

Placebo

Placebo Comparator

AR882 matching placebo taken once daily for 12 months

Intervention: Placebo (Drug)

AR882 50 mg

Experimental

AR882 50 mg taken once daily for 12 months

Intervention: AR882 50 mg (Drug)

Outcomes

Primary Outcomes

Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

Time Frame: 24 weeks

Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6

Secondary Outcomes

  • Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12(12 weeks)
  • No gout flares from the end of month 9 to the end of month 12(12 weeks)
  • Change in tophus burden by month 12(48 weeks)
  • Incidence of Adverse Events(56 weeks)
  • Change in tophus burden by month 6(24 weeks)

Investigators

Sponsor
Arthrosi Therapeutics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (134)

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