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)

Who can take part

• Males or females ≥18 years of age
• Weight within the range of 50.0 - 150.0 kg
• 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
• Willing to discontinue any oral ULT
• Females who are sterile, postmenopausal, or non-pregnant and using birth control methods

Who cannot take part

• Prior exposure to any experimental or marketed uricase
• History of significant hematologic or autoimmune disorders within 5 years of Screening and/or patient is immunocompromised or treated with immunosuppressive medications
• Non-compensated CHF or hospitalization for CHF (Stage 3-4 NYHA Functional Class) within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled BP (>160/100 mmHg) at screening and prior to randomization at Week -4 (Visit 1)
• Any condition known to have arthritis as a clinical manifestation
• Positive testing for HBV,HCV, or HIV
• Known allergy or sensitivity to the injected proteins, including pegylated products
• History of anaphylaxis, severe allergic reactions, or severe atopy
• Chronic liver disease
• Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis
• Has known latent autoimmune diabetes of adult
• History or treatment of malignancy in the last 5 years, excluding localized, nonmelanoma skin cancers (e.g. basal or squamous cell)
• Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs
• Current liver disease, as determined by ALT or AST levels above upper limit of normal at Screening Visit
• Hemoglobin <11 g/dL, neutrophil count <1500 /µl, or platelet count <100,000 /µl
• eGFR ≤ 40 mL/min/1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis
• Has uncontrolled type 2 diabetes at Screening with HbA1c ≥8.5%. Patients with type 1 diabetes will be excluded
• The patient is a pregnant or lactating female or plans to become pregnant during the study period
• G6PD deficiency or known catalase deficiency
• Known intolerance and/or known contraindication to MTX treatment or MTX treatment considered inappropriate
• Immunocompromised state, regardless of etiology