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)
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)
1 other identifier
interventional
150
3 countries
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 11, 2026
May 1, 2026
1.9 years
December 3, 2025
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Proportion of patients who achieve a reduction in sUA to \<6.0 mg/dL for at least 80% of the time during Month 6
6 months of treatment
Secondary Outcomes (2)
Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) at different time points
3 to 6 months of treatment
Treatment-emergent adverse events (TEAEs)
From enrollment to 8 months of study
Study Arms (6)
E4W with placebo-MTX
EXPERIMENTALIV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
E4W with MTX
EXPERIMENTALIV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with MTX
E6W with MTX
EXPERIMENTALIV infusion of PRX-115 every 6 weeks (E6W) for a total of 4 doses with MTX
E8W with MTX
EXPERIMENTALIV infusion of PRX-115 every 8 weeks (E8W) for a total of 3 doses with MTX
placebo E4W
PLACEBO COMPARATORinfusion of PRX-115 placebo every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
placebo E6W
PLACEBO COMPARATORIV infusion of PRX-115 placebo every 6 weeks (E6W) for a total of 4 doses with placebo-MTX
Interventions
Eligibility Criteria
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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Protalixlead
Study Sites (27)
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205, United States
Triwest Research Associates Llc
El Cajon, California, 91910, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Accel Research Sites - Deland Clinical Research Unit
DeLand, Florida, 32720, United States
ICR Sites East
Doral, Florida, 33125, United States
Qway Research
Hialeah, Florida, 33010, United States
Bioclinical Research Alliance, Inc
Miami, Florida, 33155, United States
D&H National Research Centers (North Miami)
Miami, Florida, 33169, United States
Well Pharma Medical Research Group
Miami, Florida, 33173, United States
Conquest Research - Lake Nona
Orlando, Florida, 32832, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32897, United States
New Horizons Research
Palmetto Bay, Florida, 33176, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606, United States
Centricity Research - Columbus Georgia Multispecialty
Columbus, Georgia, 31904, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Pioneer Research Solutions Inc
Houston, Texas, 77099, United States
Mt. Olympus Medical Research, LLC - Sugar Land
Sugar Land, Texas, 77479, United States
Aleksandre Aladashvili Clinic LLC, Georgia
Tbilisi, 0102, Georgia
Tbilisi Heart and Vascular Clinic Ltd , Georgia
Tbilisi, 0159, Georgia
Mediclub Georgia
Tbilisi, 0160, Georgia
Tbilisi Institute of Medicine, Georgia
Tbilisi, 0160, Georgia
Georgian-Dutch Hospital, Georgia
Tbilisi, 0172, Georgia
LTD First Medical Center, Georgia
Tbilisi, 0180, Georgia
HaEmek MC, Israel
Afula, 1834111, Israel
Barzilai MC, Israel
Ashkelon, 7830604, Israel
Meir MC, Israel
Kfar Saba, 4438164, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2025
First Posted
December 12, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
June 11, 2026
Record last verified: 2026-05