Gout Clinical Trial
Official title:
A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
| Verified date | February 2024 |
| Source | Arthrosi Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
| Status | Active, not recruiting |
| Enrollment | 42 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - History of gout - at least 1 measurable tophus on the hands/wrists and/or feet/ankles = 5 mm and = 30 mm in the longest diameter. - Patients who are NOT on approved ULT must have sUA > 7 mg/dL - Patients who are on medically appropriate ULT must have sUA > 6 mg/dL - Estimated Glomerular Filtration Rate (eGFR) = 45 mL/min/1.73m2 Exclusion Criteria: - Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin - Pregnant or breastfeeding - History of kidney stones |
| Country | Name | City | State |
|---|---|---|---|
| New Zealand | Arthrosi Investigative Site (201) | Auckland | |
| United States | Arthrosi Investigative Site (409) | Ann Arbor | Michigan |
| United States | Arthrosi Investigative Site (410) | Birmingham | Alabama |
| United States | Arthrosi Investigative Site (404) | Boise | Idaho |
| United States | Arthrosi Investigative Site (401) | Dallas | Texas |
| United States | Arthrosi Investigative Site (406) | Greensboro | North Carolina |
| United States | Arthrosi Investigative Site (408) | Myrtle Beach | South Carolina |
| United States | Arthrosi Investigative Site (403) | Phoenix | Arizona |
| United States | Arthrosi Investigative Site (416) | Sun City | Arizona |
| United States | Arthrosi Investigative Site (402) | Tampa | Florida |
| United States | Arthrosi Investigative Site (417) | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Arthrosi Therapeutics |
United States, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 | 12 weeks | |
| Secondary | Change from baseline in tophus area at Months 3 and 6 | Comparison of the treatment groups for tophus area as measured by digital calipers | 12 weeks and 24 weeks | |
| Secondary | Change from baseline in tophus crystal volume at Months 6 | Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography. | 24 weeks | |
| Secondary | Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 | 12 weeks | |
| Secondary | Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 | 24 weeks | |
| Secondary | Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence. | 24 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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