Phase 2 Study of PRX-115 IV Infusions With and Without Methotrexate Compared to Placebo in Adults With Gout

What this Trial Is About

Researchers are evaluating the efficacy, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of PRX-115, a recombinant pegylated Uricase, in adults with gout. This phase II, multicenter, randomized, double-blind, placebo-controlled study focuses on different intravenous infusion dosing regimens of PRX-115, with and without the immunomodulator methotrexate MTX, compared to placebos. The goal is to find the best dosing schedule and assess treatment effects over 24 weeks. Participants receive PRX-115 or placebo through intravenous infusions at varying intervals every 4 weeks six doses, every 6 weeks four doses, or every 8 weeks three doses. Some groups also receive oral methotrexate 15 mg weekly or a matching placebo. The study includes multiple treatment schedules combining these dosing regimens with or without MTX, allowing comparison of different approaches. Throughout the study, participants undergo regular assessments including blood tests to monitor serum uric acid levels, safety labs, and evaluations for adverse events. The primary outcome measures the percentage of patients achieving serum uric acid below 6 mgdL after 6 months of treatment. Safety and tolerability are closely monitored from enrollment until 8 months. The total participation length includes infusion visits and follow-up evaluations to gather comprehensive data on treatment impact and safety.

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)