drugset / Trial / NCT07280156

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)

NCT07280156

Phase 2 Recruiting 150 enrolled Protalix
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-12-22
Primary completion
2027-12
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 15 mg Oral
Subject PRX-115 Protein / enzyme biologic Intravenous

Indications