A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
Trial Parameters
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the respective placebos in adult patients with gout.
Eligibility Criteria
Inclusion Criteria: 1. Males or females ≥18 years of age. 2. Weight within the range of 50.0 - 150.0 kg. 3. Gout patients who failed to normalize sUA (\<7 mg/dL) with or without xanthine oxidase inhibitors or uricosuric agent or have contraindications to these drugs. 4. Willing to discontinue any oral ULT 5. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods. Exclusion Criteria: 1. Any condition known to have arthritis as a clinical manifestation. 2. Positive testing for HBV,HCV, or HIV. 3. The patient is a pregnant or lactating female or plans to become pregnant during the study period. 4. Known allergy or sensitivity to the injected proteins, including pegylated products. 5. Prior exposure to any experimental or marketed uricase. 6. Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs. 7. History of anaphylaxis, severe allergic reactions, or severe atopy. 8. G6PD deficiency or known catalase d