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 vizsgálat adatai

Ki végzi

Protalix

Azonosító

NCT07280156

A regiszteradat frissítve

2026. szeptember 29.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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