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GoutPhase 2RELEASENCT07280156

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 Phase 2 study testing PRX-115 and Methotrexate (MTX) in people with Gout, run by Protalix at 35 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout
What is being tested?
PRX-115 and Methotrexate (MTX)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
35 sitesin 3 countries
Study dates
22 Dec 2025to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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 angina), or uncontrolled BP (>160/100 mmHg) at screening and prior to randomization at Week -4 (Visit 1).
  • 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)

Trial locations and contacts

35 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Head of Clinical Development contact

+972-4-902-8100

info@protalix.com

35 sites in 3 countries

United States26 sites, 26 recruiting

  • Advanced Research Center, Inc

    Anaheim, California, 92805

    Recruiting

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

    Recruiting

  • Centricity Research - Columbus Georgia Multispecialty

    Columbus, Georgia, 31904

    Recruiting

  • Revival Research Institute, LLC

    Dearborn, Michigan, 48126

    Recruiting

  • Accel Research Sites - Deland Clinical Research Unit

    DeLand, Florida, 32720

    Recruiting

  • ICR Sites East

    Doral, Florida, 33125

    Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

    Recruiting

  • Triwest Research Associates Llc

    El Cajon, California, 91910

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

    Recruiting

  • Rezen Clinical Trials

    Glendale, Arizona, 85306

    Recruiting

  • Qway Research

    Hialeah, Florida, 33010

    Recruiting

  • Pioneer Research Solutions Inc

    Houston, Texas, 77099

    Recruiting

  • Imax Clinical Trials, LLC

    La Palma, California, 90623

    Recruiting

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

    Recruiting

  • Kinetic Clinical Research

    Long Beach, California, 90806

    Recruiting

  • Bioclinical Research Alliance, Inc

    Miami, Florida, 33155

    Recruiting

  • D&H National Research Centers (North Miami)

    Miami, Florida, 33169

    Recruiting

  • Well Pharma Medical Research Group

    Miami, Florida, 33173

    Recruiting

  • Conquest Research - Lake Nona

    Orlando, Florida, 32832

    Recruiting

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32897

    Recruiting

  • New Horizons Research

    Palmetto Bay, Florida, 33176

    Recruiting

  • Revive Research Institute, Inc

    Sterling Heights, Michigan, 48313

    Recruiting

  • Velocity Clinical Research

    Suffolk, Virginia, 23435

    Recruiting

  • Mt. Olympus Medical Research, LLC - Sugar Land

    Sugar Land, Texas, 77479

    Recruiting

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

    Recruiting

  • Velocity Clinical Research

    Waco, Texas, 76710

    Recruiting

Other trials in United States

Georgia6 sites, 6 recruiting

  • Aleksandre Aladashvili Clinic LLC, Georgia

    Tbilisi, 0102

    Recruiting

  • Tbilisi Heart and Vascular Clinic Ltd , Georgia

    Tbilisi, 0159

    Recruiting

  • Mediclub Georgia

    Tbilisi, 0160

    Recruiting

  • Tbilisi Institute of Medicine, Georgia

    Tbilisi, 0160

    Recruiting

  • Georgian-Dutch Hospital, Georgia

    Tbilisi, 0172

    Recruiting

  • LTD First Medical Center, Georgia

    Tbilisi, 0180

    Recruiting

Other trials in Georgia

Israel3 sites, 3 recruiting

  • HaEmek MC, Israel

    Afula, 1834111

    Recruiting

  • Barzilai MC, Israel

    Ashkelon, 7830604

    Recruiting

  • Meir MC, Israel

    Kfar Saba, 4438164

    Recruiting

Other trials in Israel

About this study

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)

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.

Read the 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).

Conditions
Gout
Being tested
PRX-115, Methotrexate (MTX), PRX-115 placebo, Placebo-Methotrexate
Keywords
gout, uricase, uric acid, hyperuricemia, PRX-115
Medical subject headings
Gout, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRX-115Biological

    intravenous (IV) infusion

  • Methotrexate (MTX)Drug

    Oral MTX 15 mg weekly

  • PRX-115 placeboOther

    intravenous (IV) infusion

  • Placebo-MethotrexateOther

    Oral Placebo-MTX weekly

Study groups in NCT07280156
Study groupRoleWhat they receive
E4W with placebo-MTXExperimentalIV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
Receives: Biological: PRX-115; Other: Placebo-Methotrexate
E4W with MTXExperimentalIV infusion of PRX-115 every 4 weeks (E4W) for a total of 6 doses with MTX
Receives: Biological: PRX-115; Drug: Methotrexate (MTX)
E6W with MTXExperimentalIV infusion of PRX-115 every 6 weeks (E6W) for a total of 4 doses with MTX
Receives: Biological: PRX-115; Drug: Methotrexate (MTX)
E8W with MTXExperimentalIV infusion of PRX-115 every 8 weeks (E8W) for a total of 3 doses with MTX
Receives: Biological: PRX-115; Drug: Methotrexate (MTX)
placebo E4WPlacebo comparatorinfusion of PRX-115 placebo every 4 weeks (E4W) for a total of 6 doses with placebo-MTX
Receives: Other: PRX-115 placebo; Other: Placebo-Methotrexate
placebo E6WPlacebo comparatorIV infusion of PRX-115 placebo every 6 weeks (E6W) for a total of 4 doses with placebo-MTX
Receives: Other: PRX-115 placebo; Other: Placebo-Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

    Proportion of patients who achieve a reduction in sUA to <6.0 mg/dL for at least 80% of the time during Month 6

    Measured: 6 months of treatment

Secondary outcomes (2)

  1. Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) at different time points

    Proportion of patients that achieve a reduction in sUA to <6.0 mg/dL for at least 80% of the time during Month 3 or 4, 5 and 6.

    Measured: 3 to 6 months of treatment

  2. Treatment-emergent adverse events (TEAEs)

    Occurrence and severity of treatment-emergent adverse events (TEAEs)

    Measured: From enrollment to 8 months of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start22 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multiple IV infusions at a fixed dose per infusion, at different treatment intervals . For different dosing regimens, PRX-115 will be tested with and without the immunomodulator, MTX.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280156
Sponsor's protocol ID
PB115-GT-201
Acronym
RELEASE
Status last verified
Sep 2026
First submitted
3 Dec 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRX-115 and Methotrexate (MTX) in people with Gout, run by Protalix at 35 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Georgia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head of Clinical Development (+972-4-902-8100, info@protalix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6 (time frame: 6 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07280156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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