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
This study is recruiting at 26 US sites in 9 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Gout
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Protalix
- Last updated on ClinicalTrials.gov
- September 29, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Rezen Clinical Trials · Glendale, AZ
Arkansas · 1
- Applied Research Center of Arkansas · Little Rock, AR
California · 4
- Advanced Research Center, Inc · Anaheim, CA
- Triwest Research Associates Llc · El Cajon, CA
- Imax Clinical Trials, LLC · La Palma, CA
- Kinetic Clinical Research · Long Beach, CA
Florida · 11
- Clinical Research of West Florida, Inc. · Clearwater, FL
- Accel Research Sites - Deland Clinical Research Unit · DeLand, FL
- ICR Sites East · Doral, FL
- Qway Research · Hialeah, FL
- Bioclinical Research Alliance, Inc · Miami, FL
- D&H National Research Centers (North Miami) · Miami, FL
- Well Pharma Medical Research Group · Miami, FL
- Combined Research Orlando Phase I-IV · Orlando, FL
- Conquest Research - Lake Nona · Orlando, FL
- New Horizons Research · Palmetto Bay, FL
- Clinical Research of West Florida, Inc. · Tampa, FL
Georgia · 1
- Centricity Research - Columbus Georgia Multispecialty · Columbus, GA
Michigan · 3
- Revival Research Institute, LLC · Dearborn, MI
- Quest Research Institute · Farmington Hills, MI
- Revive Research Institute, Inc · Sterling Heights, MI
Pennsylvania · 1
- Altoona Center for Clinical Research · Duncansville, PA
Texas · 3
- Pioneer Research Solutions Inc · Houston, TX
- Mt. Olympus Medical Research, LLC - Sugar Land · Sugar Land, TX
- Velocity Clinical Research · Waco, TX
Virginia · 1
- Velocity Clinical Research · Suffolk, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.