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)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT07280156

Run by

Protalix

People needed

150

Starts

2025-12-22

Expected to finish

2028-06-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥18 years of age.
• Weight within the range of 50.0 - 150.0 kg.
• 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.
• Willing to discontinue any oral ULT
• Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.

You may not qualify if…

• Any condition known to have arthritis as a clinical manifestation.
• Positive testing for HBV,HCV, or HIV.
• The patient is a pregnant or lactating female or plans to become pregnant during the study period.
• Known allergy or sensitivity to the injected proteins, including pegylated products.
• Prior exposure to any experimental or marketed uricase.
• Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs.
• History of anaphylaxis, severe allergic reactions, or severe atopy.
• G6PD deficiency or known catalase deficiency.
• History of significant hematologic or autoimmune disorders within 5 years of Screening and/or patient is immunocompromised or treated with immunosuppressive medications.
• 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).
• Current liver disease, as determined by ALT or AST levels above upper limit of normal at Screening Visit.
• Chronic liver disease.
• Hemoglobin <11 g/dL, neutrophil count <1500 /µl, or platelet count <100,000 /µl.
• Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis.
• eGFR ≤ 40 mL/min/1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis.
• Known intolerance and/or known contraindication to MTX treatment or MTX treatment considered inappropriate
• Has uncontrolled type 2 diabetes at Screening with HbA1c ≥8.5%. Patients with type 1 diabetes will be excluded.
• Has known latent autoimmune diabetes of adult.
• Immunocompromised state, regardless of etiology.
• History or treatment of malignancy in the last 5 years, excluding localized, nonmelanoma skin cancers (e.g. basal or squamous cell)

Where it is running

• Applied Research Center of Arkansas — Little Rock, Arkansas, United States (enrolling)
• Triwest Research Associates Llc — El Cajon, California, United States (enrolling)
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States (enrolling)
• Accel Research Sites - Deland Clinical Research Unit — DeLand, Florida, United States (enrolling)
• ICR Sites East — Doral, Florida, United States (enrolling)
• Qway Research — Hialeah, Florida, United States (enrolling)
• Bioclinical Research Alliance, Inc — Miami, Florida, United States (enrolling)
• D&H National Research Centers (North Miami) — Miami, Florida, United States (enrolling)
• Well Pharma Medical Research Group — Miami, Florida, United States (enrolling)
• Conquest Research - Lake Nona — Orlando, Florida, United States (enrolling)
• Combined Research Orlando Phase I-IV — Orlando, Florida, United States (enrolling)
• New Horizons Research — Palmetto Bay, Florida, United States (enrolling)
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States (enrolling)
• Centricity Research - Columbus Georgia Multispecialty — Columbus, Georgia, United States (enrolling)
• Quest Research Institute — Farmington Hills, Michigan, United States (enrolling)
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States (enrolling)
• Pioneer Research Solutions Inc — Houston, Texas, United States (enrolling)
• Mt. Olympus Medical Research, LLC - Sugar Land — Sugar Land, Texas, United States (enrolling)
• Aleksandre Aladashvili Clinic LLC, Georgia — Tbilisi, Georgia (enrolling)
• Tbilisi Heart and Vascular Clinic Ltd , Georgia — Tbilisi, Georgia (enrolling)
• Mediclub Georgia — Tbilisi, Georgia (enrolling)
• Tbilisi Institute of Medicine, Georgia — Tbilisi, Georgia (enrolling)
• Georgian-Dutch Hospital, Georgia — Tbilisi, Georgia (enrolling)
• LTD First Medical Center, Georgia — Tbilisi, Georgia (enrolling)
• HaEmek MC, Israel — Afula, Israel (enrolling)

Full record on ClinicalTrials.gov

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