Gout Clinical Trial
Official title:
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
| Verified date | May 2023 |
| Source | Arthrosi Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | November 17, 2022 |
| Est. primary completion date | November 17, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Arthrosi investigative Site | Botany | New South Wales |
| Australia | Arthrosi Investigative Site | Melbourne | Camberwell |
| Taiwan | Arthrosi Investigative Site | Taichung City | |
| Taiwan | Arthrosi Investigative Site | Taipei City | |
| Taiwan | Arthrosi Investigative Site - 301 | Taipei City | |
| Taiwan | Arthrosi Investigative Site - 304 | Taipei City | |
| Taiwan | Arthrosi Investigative Site | Taoyuan | |
| United States | Arthrosi Investigative Site | Cleveland | Ohio |
| United States | Arthrosi Investigative Site | Cleveland | Ohio |
| United States | Arthrosi Investigative Site | Dallas | Texas |
| United States | Arthrosi Investigative Site | Duncansville | Pennsylvania |
| United States | Arthrosi Investigative Site | Gilbert | Arizona |
| United States | Arthrosi Investigative Site | Glendale | Wisconsin |
| United States | Arthrosi Investigative Site | Honolulu | Hawaii |
| United States | Arthrosi Investigative Site | Houston | Texas |
| United States | Arthrosi Investigative Site | Miami | Florida |
| United States | Arthrosi Investigative Site | Miami Lakes | Florida |
| United States | Arthrosi Investigative Site | Overland Park | Kansas |
| United States | Arthrosi Investigative Site | Sun City | Arizona |
| United States | Arthrosi Investigative Site | Tampa | Florida |
| United States | Arthrosi Investigative Site | Tomball | Texas |
| United States | Arthrosi Investigative Site | Tucson | Arizona |
| United States | Arthrosi Investigative Site | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Arthrosi Therapeutics |
United States, Australia, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing | 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 | 6 weeks | |
| Secondary | sUA levels < 5, < 4, and < 3 mg/dL | Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL | 6 weeks | |
| Secondary | Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence. | 14 weeks | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax. | 12 weeks | |
| Secondary | Time to observed Cmax (Tmax) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax. | 12 weeks | |
| Secondary | Area under the plasma concentration-time curve (AUC) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC. | 12 weeks |
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