Actively Recruiting
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)
Led by Protalix · Updated on 2026-02-25
150
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females 18 years of age or older
- Weight between 50.0 and 150.0 kg
- Diagnosis of gout with serum uric acid levels not normalized (<7 mg/dL) despite treatment or contraindications to xanthine oxidase inhibitors or uricosuric agents
- Willingness to discontinue any oral urate-lowering therapy
- Females must be sterile, postmenopausal, or non-pregnant and using birth control methods
You will not qualify if you...
- Any form of arthritis as a clinical symptom
- Positive test for hepatitis B, hepatitis C, or HIV
- Pregnant or breastfeeding females, or planning pregnancy during the study
- Known allergy or sensitivity to injected proteins including pegylated products
- Previous exposure to any experimental or marketed uricase
- Use of medications affecting urate metabolism or clearance such as urate-lowering therapies
- History of anaphylaxis, severe allergic reactions, or severe atopy
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency or catalase deficiency
- Significant hematologic or autoimmune disorders within 5 years or immunocompromised status
- Uncompensated congestive heart failure or recent hospitalization for severe heart failure, uncontrolled arrhythmia, acute coronary syndrome treatment, or uncontrolled blood pressure
- Current or chronic liver disease with elevated liver enzymes
- Hemoglobin below 11 g/dL, neutrophil count below 1500/µl, or platelet count below 100,000/µl
- Severe pulmonary fibrosis, bronchiectasis, or interstitial pneumonitis
- Estimated glomerular filtration rate ≤ 40 mL/min/1.73 m2, kidney transplant, or dialysis requirement
- Known intolerance or contraindication to methotrexate or inappropriate methotrexate use
- Uncontrolled type 2 diabetes with HbA1c ≥ 8.5% or diagnosis of type 1 diabetes
- Known latent autoimmune diabetes in adults
- Immunocompromised state for any reason
- History or treatment of malignancy within 5 years except localized nonmelanoma skin cancers (basal or squamous cell)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Bioclinical Research Alliance, Inc
Miami, Florida, United States, 33155
Actively Recruiting
Research Team
H
Head of Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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