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Taking people in United StatesPhase 2

PRX-115 infusions, with or without methotrexate, for adults with gout

Tests PRX-115 given by infusion, with or without methotrexate, in adults with gout.

Key facts

Who runs it
Protalix
Where
Anaheim, Clearwater, Columbus, Dearborn, DeLand, Doral, Duncansville, El Cajon, Farmington Hills, Glendale, Hialeah, Houston, La Palma, Little Rock, Long Beach, Miami, Orlando, Palmetto Bay, Sterling Heights, Suffolk, Sugar Land, Tampa, and Waco, United StatesSee the 26 sitesAlso in 2 other countries, 9 sites
Trial code
Registry title
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)
Status
Recruiting
Phase
Phase 2
People taking part
150 people, planned
Started
22 Dec 2025
Expected to end
Jun 2028
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • PRX-115
  • Methotrexate (MTX)
  • PRX-115 placebo
  • Placebo-Methotrexate
Record updated
29 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with gout whose blood uric acid level did not come down below 7 mg/dL with usual uric acid-lowering drugs, or who cannot take those drugs.

Age
18 years and older.
Sex
Men and women can join.
Disease stage
Gout where serum uric acid (sUA) stayed at or above 7 mg/dL, with or without xanthine oxidase inhibitors or a uricosuric agent. People who have contraindications to these drugs can also join. Weight must be 50.0 - 150.0 kg (110–331 lb).
Earlier treatment
People must be willing to stop any uric acid-lowering pills (oral ULT). People who ever had any experimental or marketed uricase cannot join.
Biomarker or test result
Serum uric acid not normalized (<7 mg/dL not reached).

Main reasons for not taking part

  • Pregnant or breastfeeding women, or planning a pregnancy during the study.
  • Positive test for HBV, HCV or HIV.
  • Weakened immune system, immunosuppressive drugs, or G6PD or catalase deficiency.
  • eGFR ≤ 40 mL/min/1.73m2, a kidney transplant, or needing dialysis.
  • Cannot take MTX, or severe allergy or anaphylaxis in the past, including to pegylated products.

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

Also in 2 other countries, 9 sites

  • Advanced Research Center, Inc.Anaheim, United StatesContact: Head of Clinical DevelopmentTaking people
  • Clinical Research of West Florida, Inc.Clearwater, United StatesContact: Head of Clinical DevelopmentTaking people
  • Centricity Research Columbus Georgia MultispecialtyColumbus, United StatesContact: Head of Clinical DevelopmentTaking people
  • Revival Research Institute, LLCDearborn, United StatesContact: Head of Clinical DevelopmentTaking people
  • Accel Research Sites - DeLand Clinical Research UnitDeLand, United StatesContact: Head of Clinical DevelopmentTaking people
  • ICR Sites EastDoral, United StatesContact: Head of Clinical DevelopmentTaking people
  • Altoona Center For Clinical ResearchDuncansville, United StatesContact: Head of Clinical DevelopmentTaking people
  • TriWest Research Associates LLCEl Cajon, United StatesContact: Head of Clinical DevelopmentTaking people
  • QUEST Research InstituteFarmington Hills, United StatesContact: Head of Clinical DevelopmentTaking people
  • Rezen Clinical TrialsGlendale, United StatesContact: Head of Clinical DevelopmentTaking people
  • Qway ResearchHialeah, United StatesContact: Head of Clinical DevelopmentTaking people
  • Pioneer Research Solutions, Inc.Houston, United StatesContact: Head of Clinical DevelopmentTaking people
  • Imax Clinical Trials, LLCLa Palma, United StatesContact: Head of Clinical DevelopmentTaking people
  • Applied Research Center of ArkansasLittle Rock, United StatesContact: Head of Clinical DevelopmentTaking people
  • Kinetic Clinical ResearchLong Beach, United StatesContact: Head of Clinical DevelopmentTaking people
  • Bioclinical Research Alliance Inc.Miami, United StatesContact: Head of Clinical DevelopmentTaking people
  • D&H National Research Centers (North Miami)Miami, United StatesContact: Head of Clinical DevelopmentTaking people
  • Well Pharma Medical Research GroupMiami, United StatesContact: Head of Clinical DevelopmentTaking people
  • Combined Research Orlando Phase I-IVOrlando, United StatesContact: Head of Clinical DevelopmentTaking people
  • Conquest Research - Lake NonaOrlando, United StatesContact: Head of Clinical DevelopmentTaking people
  • New Horizons ResearchPalmetto Bay, United StatesContact: Head of Clinical DevelopmentTaking people
  • Revive Research Institute, Inc.Sterling Heights, United StatesContact: Head of Clinical DevelopmentTaking people
  • Velocity Clinical ResearchSuffolk, United StatesContact: Head of Clinical DevelopmentTaking people
  • Mt. Olympus Medical Research, LLC - Sugar LandSugar Land, United StatesContact: Head of Clinical DevelopmentTaking people
  • Clinical Research of West Florida IncTampa, United StatesContact: Head of Clinical DevelopmentTaking people
  • Velocity Clinical ResearchWaco, United StatesContact: Head of Clinical DevelopmentTaking people

About the trial

What the trial wants to find out

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.

The 6 groups in the trial

  • E4W with placebo-MTXTreatment being tested

    IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with placebo-MTX

    Treatment: PRX-115 and Placebo-Methotrexate

  • E4W with MTXTreatment being tested

    IV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with MTX

    Treatment: PRX-115 and Methotrexate (MTX)

  • E6W with MTXTreatment being tested

    IV infusion of PRX-115 every 6 weeks (E6W) for a total of 4 doses with MTX

    Treatment: PRX-115 and Methotrexate (MTX)

  • E8W with MTXTreatment being tested

    IV infusion of PRX-115 every 8 weeks (E8W) for a total of 3 doses with MTX

    Treatment: PRX-115 and Methotrexate (MTX)

  • placebo E4WPlacebo, for comparison

    infusion of PRX-115 placebo every 4 weeks (E4W) for a total of 6 doses with placebo-MTX

    Treatment: PRX-115 placebo and Placebo-Methotrexate

  • placebo E6WPlacebo, for comparison

    IV infusion of PRX-115 placebo every 6 weeks (E6W) for a total of 4 doses with placebo-MTX

    Treatment: PRX-115 placebo and Placebo-Methotrexate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
PRX-115 infusions, with or without methotrexate, for adults with goutGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
29 September 2026