A Study Assessing the Safety and Efficacy of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Compared to Placebo in Adults With Gout

What this Trial Is About

Researchers are evaluating PRX-115, a recombinant pegylated Uricase given by intravenous infusion, for its safety, effectiveness, and best dosing schedule in adults with gout who have not normalized their serum uric acid levels despite treatment or cannot use standard drugs. This phase II, randomized, double-blind, placebo-controlled study compares infusions of PRX-115 with or without methotrexate to placebos over 24 weeks. The study is led by Protalix and aims to better understand PRX-115's impact on gout and its tolerability. Participants receive PRX-115 through intravenous infusions at varying intervals: every 4, 6, or 8 weeks, combined with either methotrexate or placebo methotrexate, or they receive placebo infusions on similar schedules. The study includes multiple dosing groups to find the optimal regimen, with up to six doses over 24 weeks depending on the schedule assigned. Methotrexate is given orally once a week at 15 mg where applicable. During the study, participants undergo regular monitoring including serum uric acid tests to measure treatment response, safety assessments, and evaluations of drug behavior in the body. Researchers track the percentage of participants who maintain serum uric acid below 6 mg/dL at 6 months as the primary outcome. Additional safety and tolerability data are collected for up to 8 months. The overall participation period covers treatment and follow-up to assess long-term effects and adverse events.

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)