NCT07280156From ClinicalTrials.govRecruiting

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)

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)

Gout

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Protalix
Enrolment target: 150
Started: 22 December 2025
Main results due: December 2027
Study sites: 35
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Males or females ≥18 years of age.
2. Weight within the range of 50.0 - 150.0 kg.
3. Gout patients who failed to normalize sUA (\<7 mg/dL) with or without xanthine oxidase inhibitors or uricosuric agent or have contraindications to these drugs.
4. Willing to discontinue any oral ULT
5. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.

Exclusion Criteria:

1. Any condition known to have arthritis as a clinical manifestation.
2. Positive testing for HBV,HCV, or HIV.
3. The patient is a pregnant or lactating female or plans to become pregnant during the study period.
4. Known allergy or sensitivity to the injected proteins, including pegylated products.
5. Prior exposure to any experimental or marketed uricase.
6. Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs.
7. History of anaphylaxis, severe allergic reactions, or severe atopy.
8. G6PD deficiency or known catalase deficiency.
9. History of significant hematologic or autoimmune disorders within 5 years of Screening and/or patient is immunocompromised or treated with immunosuppressive medications.
10. Non-compensated CHF or hospitalization for CHF (Stage 3-4 NYHA Functional Class) within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled BP (\>160/100 mmHg) at screening and prior to randomization at Week -4 (Visit 1).
11. Current liver disease, as determined by ALT or AST levels above upper limit of normal at Screening Visit.
12. Chronic liver disease.
13. Hemoglobin \<11 g/dL, neutrophil count \<1500 /µl, or platelet count \<100,000 /µl.
14. Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis.
15. eGFR ≤ 40 mL/min/1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis.
16. Known intolerance and/or known contraindication to MTX treatment or MTX treatment considered inappropriate
17. Has uncontrolled type 2 diabetes at Screening with HbA1c ≥8.5%. Patients with type 1 diabetes will be excluded.
18. Has known latent autoimmune diabetes of adult.
19. Immunocompromised state, regardless of etiology.
20. History or treatment of malignancy in the last 5 years, excluding localized, nonmelanoma skin cancers (e.g. basal or squamous cell)

What this study is about

In the sponsor’s own words, from the registry.

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 sites(35)

Rezen Clinical Trials
Glendale, Arizona, United States
Recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Recruiting
Advanced Research Center, Inc
Anaheim, California, United States
Recruiting
Triwest Research Associates Llc
El Cajon, California, United States
Recruiting
Imax Clinical Trials, LLC
La Palma, California, United States
Recruiting
Kinetic Clinical Research
Long Beach, California, United States
Recruiting
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Recruiting
Accel Research Sites - Deland Clinical Research Unit
DeLand, Florida, United States
Recruiting
ICR Sites East
Doral, Florida, United States
Recruiting
Qway Research
Hialeah, Florida, United States
Recruiting
Bioclinical Research Alliance, Inc
Miami, Florida, United States
Recruiting
D&H National Research Centers (North Miami)
Miami, Florida, United States
Recruiting
Well Pharma Medical Research Group
Miami, Florida, United States
Recruiting
Conquest Research - Lake Nona
Orlando, Florida, United States
Recruiting
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
Recruiting
New Horizons Research
Palmetto Bay, Florida, United States
Recruiting
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Recruiting
Centricity Research - Columbus Georgia Multispecialty
Columbus, Georgia, United States
Recruiting
Revival Research Institute, LLC
Dearborn, Michigan, United States
Recruiting
Quest Research Institute
Farmington Hills, Michigan, United States
Recruiting
Revive Research Institute, Inc
Sterling Heights, Michigan, United States
Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Recruiting
Pioneer Research Solutions Inc
Houston, Texas, United States
Recruiting
Mt. Olympus Medical Research, LLC - Sugar Land
Sugar Land, Texas, United States
Recruiting
Velocity Clinical Research
Waco, Texas, United States
Recruiting
Velocity Clinical Research
Suffolk, Virginia, United States
Recruiting
Aleksandre Aladashvili Clinic LLC, Georgia
Tbilisi, Georgia
Recruiting
Tbilisi Heart and Vascular Clinic Ltd , Georgia
Tbilisi, Georgia
Recruiting
Mediclub Georgia
Tbilisi, Georgia
Recruiting
Tbilisi Institute of Medicine, Georgia
Tbilisi, Georgia
Recruiting
Georgian-Dutch Hospital, Georgia
Tbilisi, Georgia
Recruiting
LTD First Medical Center, Georgia
Tbilisi, Georgia
Recruiting
HaEmek MC, Israel
Afula, Israel
Recruiting
Barzilai MC, Israel
Ashkelon, Israel
Recruiting
Meir MC, Israel
Kfar Saba, Israel
Recruiting

Showing 35 of 35 sites. 35 of the 35 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07280156. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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