Clinical Trial

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)

Study acronym: RELEASE
Recruiting Phase 2
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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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 18 -> 27 locations 2026-05-30
notable Trial sites expanded: 1 -> 18 locations 2026-05-29
Trial Details
NCT Number NCT07280156
Lead Sponsor Protalix
Conditions Gout
Enrollment 150 participants
Start Date 2025-12-22
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-11