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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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 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)

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) (NCT07280156) is a Phase 2 interventional studying Gout, sponsored by Protalix. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gout and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gout subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

BIOLOGICAL

PRX-115

intravenous (IV) infusion

DRUG

Methotrexate (MTX)

Oral MTX 15 mg weekly

OTHER

PRX-115 placebo

intravenous (IV) infusion

OTHER

Placebo-Methotrexate

Oral Placebo-MTX weekly

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Bioclinical Research Alliance, Inc
Miami, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07280156), the sponsor (Protalix), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07280156 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07280156?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07280156?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07280156. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07280156. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.