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)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Efficacy, Safety, and Dosing Regimen Selection of Multiple Intravenous Infusions of PRX-115 With and Without Methotrexate Versus Placebo in Adult Patients With Gout (RELEASE)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Applied Research Center of Arkansas — Little Rock, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- Applied Research Center of Arkansas — Little Rock, Arkansas
- Triwest Research Associates Llc — El Cajon, California
- Clinical Research of West Florida, Inc. — Clearwater, Florida
- Accel Research Sites - Deland Clinical Research Unit — DeLand, Florida
- ICR Sites East — Doral, Florida
- Qway Research — Hialeah, Florida
- Bioclinical Research Alliance, Inc — Miami, Florida
- D&H National Research Centers (North Miami) — Miami, Florida
- Well Pharma Medical Research Group — Miami, Florida
- Conquest Research - Lake Nona — Orlando, Florida
- Combined Research Orlando Phase I-IV — Orlando, Florida
- New Horizons Research — Palmetto Bay, Florida
- Clinical Research of West Florida, Inc. — Tampa, Florida
- Centricity Research - Columbus Georgia Multispecialty — Columbus, Georgia
- Quest Research Institute — Farmington Hills, Michigan
- Altoona Center for Clinical Research — Duncansville, Pennsylvania
- Pioneer Research Solutions Inc — Houston, Texas
- Mt. Olympus Medical Research, LLC - Sugar Land — Sugar Land, Texas
- Aleksandre Aladashvili Clinic LLC, Georgia — Tbilisi,
- Tbilisi Heart and Vascular Clinic Ltd , Georgia — Tbilisi,
- Mediclub Georgia — Tbilisi,
- Tbilisi Institute of Medicine, Georgia — Tbilisi,
- Georgian-Dutch Hospital, Georgia — Tbilisi,
- LTD First Medical Center, Georgia — Tbilisi,
- HaEmek MC, Israel — Afula,
📞 Contact the Study Coordinator
Phone: +972-4-902-8100
Email: info@protalix.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. — Sacramento, California
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- Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301) — Birmingham, Alabama
Explore by condition: All Gout clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.