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Compares treatment options for Gout
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)
ClinicalTrials.gov ID: NCT07280156
What this study is testing
What is PRX-115?
PRX-115 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gout.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Willing to discontinue any oral ULT
- Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- El Cajon, California, United States
- Clearwater, Florida, United States
- DeLand, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Palmetto Bay, Florida, United States
- Tampa, Florida, United States
- Columbus, Georgia, United States
- Farmington Hills, Michigan, United States
- Duncansville, Pennsylvania, United States
- Houston, Texas, United States
- Sugar Land, Texas, United States
- Tbilisi, Georgia
- Afula, Israel
- Ashkelon, Israel
- Kfar Saba, Israel
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; El Cajon, California, United States; Clearwater, Florida, United States; DeLand, Florida, United States; Doral, Florida, United States; Hialeah, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.