IV PRX-115 at different dose schedules, with or without methotrexate, versus placebo for adults with gout

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial testing multiple IV infusions of PRX-115 over 24 weeks with treatment arms that include or omit methotrexate and matching placebos. Participants are assigned to different dosing regimens to identify the best balance of efficacy and tolerability. The study measures serum uric acid lowering, safety and tolerability, pharmacokinetics/pharmacodynamics, and immunogenicity (anti-drug antibodies). Dosing regimen selection will be informed by both clinical response and antibody/PK profiles.

Why it matters

Who can join: the full rules

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)

Where it's running

• Rezen Clinical Trials
  Glendale, Arizona, United States Recruiting
• Applied Research Center of Arkansas
  Little Rock, Arkansas, United States Recruiting
• Advanced Research Center, Inc
  Anaheim, California, United States Recruiting
• Triwest Research Associates Llc
  El Cajon, California, United States Recruiting
• Imax Clinical Trials, LLC
  La Palma, California, United States Recruiting
• Kinetic Clinical Research
  Long Beach, California, United States Recruiting

Study contacts

• Study coordinator: Head of Clinical Development
• Email: info@protalix.com
• Phone: +972-4-902-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.