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)
Protalix
150 participants
Dec 22, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria20
- 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)
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Interventions
intravenous (IV) infusion
Oral MTX 15 mg weekly
intravenous (IV) infusion
Oral Placebo-MTX weekly
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07280156