Study of PRX-115 for Gout Treatment (RELEASE)

This study is testing PRX-115, a new intravenous (IV) infusion, to see how well it works and if it's safe for adults with gout. You might also receive methotrexate (MTX), a common medication, or a placebo (inactive substance). The study aims to enroll about 150 participants who are at least 18 years old, weigh between 50 and 150 kg, and whose gout hasn't been controlled by other treatments or who can't take those treatments. The main goal is to see what percentage of participants have their serum uric acid (sUA) levels drop below 6 mg/dL after 6 months of treatment. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to different treatment groups, and neither you nor your doctors will know which treatment you are receiving. It is a Phase II study, and plans to enroll about 150 participants.
What's involved
Participants will receive PRX-115 or a placebo through intravenous (IV) infusions over 24 weeks, according to different schedules. You may also take oral methotrexate or a placebo weekly.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months of treatment, focusing on serum uric acid levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Protalix
~150 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:PRX-115Methotrexate (MTX)PRX-115 placeboPlacebo-Methotrexate

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Measured over 6 months of treatment
Gout
27 sites across 8 states
Florida11
Georgia7
Israel3
Texas2
Arkansas1
California1
Michigan1
Pennsylvania1

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  • Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 66 months of treatment

    Proportion of patients who achieve a reduction in sUA to \<6.0 mg/dL for at least 80% of the time during Month 6