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

Arthrosi Therapeutics42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gout Arthritis, Gouty Hyperuricemia Gout Chronic

Interventions

AR882 Dose 1DRUG

Solid Oral Capsule

AR882 Dose 2DRUG

Solid Oral Capsule

Allopurinol TabletDRUG

Solid tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Arthrosi Investigative Site (410)

Birmingham, Alabama, United States

Arthrosi Investigative Site (403)

Phoenix, Arizona, United States

Arthrosi Investigative Site (416)

Sun City, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

Change from baseline in tophus area at Months 3 and 6

Comparison of the treatment groups for tophus area as measured by digital calipers

Time frame: 12 weeks and 24 weeks

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.

Time frame: 24 weeks

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

Time frame: 12 weeks

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

Time frame: 24 weeks

Incidence of Adverse Events

Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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