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Recruiting Phase 2 Interventional

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)

ClinicalTrials.gov ID: NCT07280156

Public ClinicalTrials.gov record NCT07280156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07280156
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Protalix
Industry
Enrollment
150 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 22, 2025 (Actual)
Primary completion
Dec 2027 (Estimated)
Completion
Jun 2028 (Estimated)
Last update posted
Sep 29, 2026

2025 – 2028

United States locations

U.S. sites
26
U.S. states
9
U.S. cities
23
Facility City State ZIP Site status
Rezen Clinical Trials Glendale Arizona 85306 Recruiting
Applied Research Center of Arkansas Little Rock Arkansas 72205 Recruiting
Advanced Research Center, Inc Anaheim California 92805 Recruiting
Triwest Research Associates Llc El Cajon California 91910 Recruiting
Imax Clinical Trials, LLC La Palma California 90623 Recruiting
Kinetic Clinical Research Long Beach California 90806 Recruiting
Clinical Research of West Florida, Inc. Clearwater Florida 33765 Recruiting
Accel Research Sites - Deland Clinical Research Unit DeLand Florida 32720 Recruiting
ICR Sites East Doral Florida 33125 Recruiting
Qway Research Hialeah Florida 33010 Recruiting
Bioclinical Research Alliance, Inc Miami Florida 33155 Recruiting
D&H National Research Centers (North Miami) Miami Florida 33169 Recruiting
Well Pharma Medical Research Group Miami Florida 33173 Recruiting
Conquest Research - Lake Nona Orlando Florida 32832 Recruiting
Combined Research Orlando Phase I-IV Orlando Florida 32897 Recruiting
New Horizons Research Palmetto Bay Florida 33176 Recruiting
Clinical Research of West Florida, Inc. Tampa Florida 33606 Recruiting
Centricity Research - Columbus Georgia Multispecialty Columbus Georgia 31904 Recruiting
Revival Research Institute, LLC Dearborn Michigan 48126 Recruiting
Quest Research Institute Farmington Hills Michigan 48334 Recruiting
Revive Research Institute, Inc Sterling Heights Michigan 48313 Recruiting
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 Recruiting
Pioneer Research Solutions Inc Houston Texas 77099 Recruiting
Mt. Olympus Medical Research, LLC - Sugar Land Sugar Land Texas 77479 Recruiting
Velocity Clinical Research Waco Texas 76710 Recruiting
Velocity Clinical Research Suffolk Virginia 23435 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07280156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 29, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07280156 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →