Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

Phase 2

Completed

Interventions: Drug: Allopurinol Tablet
Drug: AR882 Dose 1
Drug: AR882 Dose 2

Brief Summary: 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Group 1	Allopurinol Tablet	Allopurinol once daily for 24 weeks
Group 2	AR882 Dose 1	AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
Group 2	AR882 Dose 2	AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
Group 3	AR882 Dose 1	AR882 Dose 1 + Allopurinol for 24 weeks
Group 3	Allopurinol Tablet	AR882 Dose 1 + Allopurinol for 24 weeks

Primary Outcome Measures

Name	Time	Method
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3	12 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 5 mg/dL at month 3

Secondary Outcome Measures

Name	Time	Method
Change from baseline in tophus area at Months 3 and 6	12 weeks and 24 weeks	Comparison of the treatment groups for tophus area as measured by digital calipers
Change from baseline in tophus crystal volume at Months 6	24 weeks	Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3	12 weeks	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
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6	24 weeks	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
Incidence of Adverse Events	24 weeks	Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Locations (12): Arthrosi Investigative Site (404)
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Boise, Idaho, United States
Arthrosi Investigative Site (406)
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Greensboro, North Carolina, United States
Arthrosi Investigative Site (401)
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Dallas, Texas, United States
Arthrosi Investigative Site (303)
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Taichung, Taiwan
Arthrosi Investigative Site (402)
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Tampa, Florida, United States
Arthrosi Investigative Site (409)
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Ann Arbor, Michigan, United States
Arthrosi Investigative Site (416)
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Sun City, Arizona, United States
Arthrosi Investigative Site (410)
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Birmingham, Alabama, United States
Arthrosi Investigative Site (417)
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Tucson, Arizona, United States
Arthrosi Investigative Site (201)
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Auckland, New Zealand
Arthrosi Investigative Site (408)
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Myrtle Beach, South Carolina, United States
Arthrosi Investigative Site (403)
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Phoenix, Arizona, United States