NCT05119686CompletedPhase 2
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Arthrosi Therapeutics4 sites in 2 countries140 target enrollmentStarted: November 16, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 4
- Primary Endpoint
- Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
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 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of gout
- •sUA > 7 mg/dL
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2
Exclusion Criteria
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •History of kidney stones
Arms & Interventions
Group 1
Experimental
AR882 Dose 1 x 12 weeks
Intervention: AR882 Dose 1 (Drug)
Group 2
Experimental
AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
Intervention: AR882 Dose 1 (Drug)
Group 2
Experimental
AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
Intervention: AR882 Dose 2 (Drug)
Group 3
Placebo Comparator
AR882 matching placebo x 12 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
Time Frame: 6 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL following 6 weeks of dosing
Secondary Outcomes
- sUA levels < 5, < 4, and < 3 mg/dL(6 weeks)
- Incidence of Adverse Events(14 weeks)
- Maximum Observed Plasma Concentration (Cmax)(12 weeks)
- Time to observed Cmax (Tmax)(12 weeks)
- Area under the plasma concentration-time curve (AUC)(12 weeks)
Investigators
Study Sites (4)
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