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Study identifier: NCT07280156 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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)

Condition: Gout  ·  Sponsor: Protalix

PhasePhase 2
Planned participants150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Head of Clinical Development  ·  +972-4-902-8100  ·  info@protalix.com

Always discuss trial participation with your own doctor first.

Locations (27)

Applied Research Center of ArkansasLittle Rock, Arkansas, United StatesRecruiting
Triwest Research Associates LlcEl Cajon, California, United StatesRecruiting
Clinical Research of West Florida, Inc.Clearwater, Florida, United StatesRecruiting
Accel Research Sites - Deland Clinical Research UnitDeLand, Florida, United StatesRecruiting
ICR Sites EastDoral, Florida, United StatesRecruiting
Qway ResearchHialeah, Florida, United StatesRecruiting
Bioclinical Research Alliance, IncMiami, Florida, United StatesRecruiting
D&H National Research Centers (North Miami)Miami, Florida, United StatesRecruiting
Well Pharma Medical Research GroupMiami, Florida, United StatesRecruiting
Conquest Research - Lake NonaOrlando, Florida, United StatesRecruiting
Combined Research Orlando Phase I-IVOrlando, Florida, United StatesRecruiting
New Horizons ResearchPalmetto Bay, Florida, United StatesRecruiting

+ 15 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07280156