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New hope for stubborn gout: experimental drug PRX-115 enters phase 2 trial

NCT ID NCT07280156

Disease control Sponsor: Protalix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called PRX-115, given through a vein, to see if it can lower uric acid levels in adults with gout who haven't improved with standard pills. About 150 participants will receive either PRX-115 (with or without methotrexate) or a placebo over 24 weeks. The main goal is to find the best dose and check if the drug safely reduces uric acid below the target level.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

gout Hyperuricemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    27 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Accel Research Sites - Deland Clinical Research Unit

    RECRUITING

    DeLand, Florida, 32720, United States

  • Aleksandre Aladashvili Clinic LLC, Georgia

    RECRUITING

    Tbilisi, 0102, Georgia

  • Altoona Center for Clinical Research

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Applied Research Center of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Barzilai MC, Israel

    RECRUITING

    Ashkelon, 7830604, Israel

  • Bioclinical Research Alliance, Inc

    RECRUITING

    Miami, Florida, 33155, United States

  • Centricity Research - Columbus Georgia Multispecialty

    RECRUITING

    Columbus, Georgia, 31904, United States

  • Clinical Research of West Florida, Inc.

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida, Inc.

    RECRUITING

    Tampa, Florida, 33606, United States

  • Combined Research Orlando Phase I-IV

    RECRUITING

    Orlando, Florida, 32897, United States

  • Conquest Research - Lake Nona

    RECRUITING

    Orlando, Florida, 32832, United States

  • D&H National Research Centers (North Miami)

    RECRUITING

    Miami, Florida, 33169, United States

  • Georgian-Dutch Hospital, Georgia

    RECRUITING

    Tbilisi, 0172, Georgia

  • HaEmek MC, Israel

    RECRUITING

    Afula, 1834111, Israel

  • ICR Sites East

    RECRUITING

    Doral, Florida, 33125, United States

  • LTD First Medical Center, Georgia

    RECRUITING

    Tbilisi, 0180, Georgia

  • Mediclub Georgia

    RECRUITING

    Tbilisi, 0160, Georgia

  • Meir MC, Israel

    RECRUITING

    Kfar Saba, 4438164, Israel

  • Mt. Olympus Medical Research, LLC - Sugar Land

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • New Horizons Research

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

  • Pioneer Research Solutions Inc

    RECRUITING

    Houston, Texas, 77099, United States

  • Quest Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Qway Research

    RECRUITING

    Hialeah, Florida, 33010, United States

  • Tbilisi Heart and Vascular Clinic Ltd , Georgia

    RECRUITING

    Tbilisi, 0159, Georgia

  • Tbilisi Institute of Medicine, Georgia

    RECRUITING

    Tbilisi, 0160, Georgia

  • Triwest Research Associates Llc

    RECRUITING

    El Cajon, California, 91910, United States

  • Well Pharma Medical Research Group

    RECRUITING

    Miami, Florida, 33173, United States

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