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.
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
Any condition known to have arthritis as a clinical manifestation.
Positive testing for HBV,HCV, or HIV.
The patient is a pregnant or lactating female or plans to become pregnant during the study period.
Known allergy or sensitivity to the injected proteins, including pegylated products.
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Treatment groupsSee each treatment group below.
Protalix
Lead sponsor