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NCT07280156 | RECRUITING | Gout

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)
Sponsor:

Protalix

Brief 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.

Condition or disease

Gout

Intervention/treatment

PRX-115

Methotrexate (MTX)

PRX-115 placebo

Placebo-Methotrexate

Phase

PHASE2

Detailed Description:

This study will evaluate the efficacy, safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PRX-115 (a recombinant pegylated Uricase) in adult patients with gout. Participants will receive PRX-115 by intravenous (IV) infusions according to different treatment schedules, with and without the immunomodulator methotrexate (MTX).

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2025-12-22
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2028-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Males or females ≥18 years of age.
  • 2. Weight within the range of 50.0 - 150.0 kg.
  • 3. 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.
  • 4. Willing to discontinue any oral ULT
  • 5. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.
Exclusion Criteria
  • 1. Any condition known to have arthritis as a clinical manifestation.
  • 2. Positive testing for HBV,HCV, or HIV.
  • 3. The patient is a pregnant or lactating female or plans to become pregnant during the study period.
  • 4. Known allergy or sensitivity to the injected proteins, including pegylated products.
  • 5. Prior exposure to any experimental or marketed uricase.
  • 6. Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs.
  • 7. History of anaphylaxis, severe allergic reactions, or severe atopy.
  • 8. G6PD deficiency or known catalase deficiency.
  • 9. History of significant hematologic or autoimmune disorders within 5 years of Screening and/or patient is immunocompromised or treated with immunosuppressive medications.
  • 10. 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).
  • 11. Current liver disease, as determined by ALT or AST levels above upper limit of normal at Screening Visit.
  • 12. Chronic liver disease.
  • 13. Hemoglobin \<11 g/dL, neutrophil count \<1500 /µl, or platelet count \<100,000 /µl.
  • 14. Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis.
  • 15. eGFR ≤ 40 mL/min/1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis.
  • 16. Known intolerance and/or known contraindication to MTX treatment or MTX treatment considered inappropriate
  • 17. Has uncontrolled type 2 diabetes at Screening with HbA1c ≥8.5%. Patients with type 1 diabetes will be excluded.
  • 18. Has known latent autoimmune diabetes of adult.
  • 19. Immunocompromised state, regardless of etiology.
  • 20. History or treatment of malignancy in the last 5 years, excluding localized, nonmelanoma skin cancers (e.g. basal or squamous cell)
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)

Location Details

NCT07280156

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Locations

RECRUITING

United States, Florida

Bioclinical Research Alliance, Inc

Miami, florida, United States, 33155