Clinical Trials List
2021-12-01 - 2022-12-01
Phase II
Recruiting5
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 versus Placebo in Gout Patients
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Trial Applicant
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Sponsor
Arthrosi Therapeutics
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chang-Youh Tsai Division of Rheumatology
- C. D. CHOU 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
AR882
Dosage Form
Dosage
75 mg/capsule
Endpoints
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 Outcome Measures :
sUA levels < 5, < 4, and < 3 mg/dL [ Time Frame: 6 weeks ]
Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL
Incidence of Adverse Events [ Time Frame: 14 weeks ]
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 12 weeks ]
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.
Time to observed Cmax (Tmax) [ Time Frame: 12 weeks ]
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.
Area under the plasma concentration-time curve (AUC) [ Time Frame: 12 weeks ]
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.
Inclution 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
The Estimated Number of Participants
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Taiwan
30 participants
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Global
120 participants
