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)

Trial details

Who runs it

Protalix

Trial code

NCT07280156

Record updated

29 September 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT07280156