Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

Phase 2CompletedNCT05119686

Arthrosi Therapeutics140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Gout Arthritis, Gouty Hyperuricemia Gout Chronic

Interventions

AR882 Dose 1DRUG

Solid Oral Capsule

AR882 Dose 2DRUG

Solid Oral Capsule

PlaceboDRUG

Matching Solid Oral Capsule Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (23)

Arthrosi Investigative Site

Gilbert, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 weeks

Incidence of Adverse Events

Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Time frame: 14 weeks

Maximum Observed Plasma Concentration (Cmax)

Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.

Time frame: 12 weeks

Time to observed Cmax (Tmax)

Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.

Time frame: 12 weeks

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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