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Gout drug pegloticase gets a shot in the arm: new subcutaneous option tested

NCT ID NCT07388498

Disease control Sponsor: Amgen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 9 times

Summary

This phase 3 trial tests whether a subcutaneous (under-the-skin) injection of pegloticase works as well as the standard intravenous (IV) infusion for people with uncontrolled gout. About 270 adults will receive either the shot or the IV, both with weekly methotrexate. The goal is to see if uric acid levels stay normal for most of the sixth month of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pegloticase (KRYSTEXXA) with methotrexate
What this could lead to
If successful, this could offer a more convenient subcutaneous injection option for controlling gout, reducing the need for intravenous infusions.
What could go wrong
This is a phase 3 trial, but results may not confirm superiority or non-inferiority of the SC route. Risks include injection site reactions and allergic reactions.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

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

Started

Feb 2026

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 * Participant has provided informed consent before initiation of any trial-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. * Participants with uncontrolled gout, as meeting the protocol defined criteria. Exclusion Criteria * Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit). * Liver transaminase levels (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) \> 1.25 x upper limit of normal (ULN) or albumin \< the lower limit of normal (LLN) at the screening visit. * Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) \> 8%. * Known intolerance to MTX. * Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug. * A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone ≤ 10 mg/day or equivalent dose of other corticosteroid). * Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations \< 40 mL/min/1.73 m\^2 or currently on dialysis.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

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

Uncontrolled 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

    71 sites in 2 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

  • Accellacare Salisbury

    RECRUITING

    Salisbury, North Carolina, 28144, United States

  • Advanced Clinical Research

    RECRUITING

    Miami, Florida, 33156, United States

  • Advanced Clinical Research Center, LLC dba TriWest Research Associates

    RECRUITING

    Chula Vista, California, 91910, United States

  • Altoona Center for Clinical Research

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Arthritis Northwest Professional Limited Liability Company

    RECRUITING

    Spokane, Washington, 99204, United States

  • Arthritis and Osteoporosis Consultants of the Carolinas

    RECRUITING

    Charlotte, North Carolina, 28202, United States

  • Arthritis and Rheumatic Disease Specialties

    RECRUITING

    Aventura, Florida, 33180, United States

  • Articularis Healthcare Group Inc dba Low Country Rheumatology

    RECRUITING

    Summerville, South Carolina, 29486, United States

  • Bay Pines Veterans Affairs Healthcare System

    RECRUITING

    Bay Pines, Florida, 33744, United States

  • Be Well Clinical Studies

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Bioluminux Clinical Research - Hamilton

    RECRUITING

    Hamilton, New Jersey, 08690, United States

  • Biopharma Informatic, LLC

    RECRUITING

    Katy, Texas, 77494, United States

  • Buffalo Rheumatology and Medicine

    RECRUITING

    Orchard Park, New York, 14127, United States

  • Cape Fear Arthritis Care, PLLC

    RECRUITING

    Leland, North Carolina, 28451, United States

  • Caribbean Health Research Center

    RECRUITING

    San Juan, 00917, Puerto Rico

  • Carolina Research Center Inc

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Charter Research

    RECRUITING

    Chicago, Illinois, 60618, United States

  • ClinPro Research Solutions LLC

    RECRUITING

    Tampa, Florida, 33613, United States

  • Clinical Research Institute of Michigan

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Trials Management, LLC, d/b/a Flourish Research

    RECRUITING

    Mandeville, Louisiana, 70471, United States

  • Conquest Research - Winter Park

    RECRUITING

    Winter Park, Florida, 32789, United States

  • D and H National Research Centers

    RECRUITING

    Miami, Florida, 33155, United States

  • D and H Pompano Research Center

    RECRUITING

    Aventura, Florida, 33180, United States

  • D and H Tamarac Research Center

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Decision Management International Research

    RECRUITING

    Pinellas Park, Florida, 33782, United States

  • Denver Arthritis Clinic PC

    RECRUITING

    Denver, Colorado, 80230, United States

  • Discovery Health Research Center

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Entrust Clinical Research

    RECRUITING

    Miami, Florida, 33176, United States

  • Epic Clinical Research

    RECRUITING

    Lewisville, Texas, 75057, United States

  • Felicidad Medical Research

    RECRUITING

    Miami, Florida, 33184, United States

  • Flourish Research Ravenswood

    RECRUITING

    Chicago, Illinois, 60640, United States

  • GCP Clinical Research, LLC

    RECRUITING

    Tampa, Florida, 33609, United States

  • Greater Chicago Specialty Physicians

    RECRUITING

    Schaumburg, Illinois, 60195, United States

  • Health Concepts

    RECRUITING

    Rapid City, South Dakota, 57702, United States

  • Hillcrest Medical Research

    RECRUITING

    DeLand, Florida, 32720, United States

  • Homestead Associates In Research Inc

    RECRUITING

    Homestead, Florida, 33033, United States

  • Inspire Santa Fe Medical Group

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • Integral Rheumatology and Immunology Specialists

    RECRUITING

    Plantation, Florida, 33324, United States

  • Joint and Muscle Research Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • June DO PC

    RECRUITING

    Lansing, Michigan, 48911, United States

  • Kur Research at Columbia Medical Practice

    RECRUITING

    Columbia, Maryland, 21045, United States

  • Lynn Health Science Institute

    RECRUITING

    Oklahoma City, Oklahoma, 73111, United States

  • MD Medical Research

    RECRUITING

    Oxon Hill, Maryland, 20745, United States

  • New Generation of Medical Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Nodal Medical Center Research

    RECRUITING

    Tampa, Florida, 33607, United States

  • Oakland Medical Research Center

    RECRUITING

    Troy, Michigan, 48085, United States

  • Ohio State University Wexner Medical Center Clinical Research Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Onsite Clinical Solutions, LLC

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Orthopedic Physicians Alaska

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Overlake Arthritis and Osteoperosis Center

    RECRUITING

    Bellevue, Washington, 98004, United States

  • Paramount Medical Research and Consulting LLC

    RECRUITING

    Middleburg Heights, Ohio, 44130, United States

  • Pharmax Research Clinic

    RECRUITING

    Miami, Florida, 33126, United States

  • Pioneer Research Solutions Inc

    RECRUITING

    Houston, Texas, 77099, United States

  • Precision Rheumatology

    RECRUITING

    Anaheim, California, 92802, United States

  • Raymond G Murphy Veteran Affairs Medical Center

    RECRUITING

    Albuquerque, New Mexico, 87108, United States

  • Research Carolina Elite

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Research Physicians Network, LLC

    RECRUITING

    Houston, Texas, 77089, United States

  • Saint Lukes Intermountain Research Center

    RECRUITING

    Boise, Idaho, 83702, United States

  • Shelby Clinical Research

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Siena Research Network

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Solace Clinical Research

    RECRUITING

    Tustin, California, 92780, United States

  • Southwest Rheumatology

    RECRUITING

    Dallas, Texas, 75230, United States

  • Spatium Urgent Care

    RECRUITING

    Marietta, Georgia, 30066, United States

  • Texas Arthritis & Rheumatology Associates

    RECRUITING

    Katy, Texas, 77450, United States

  • Triad Clinical Trials, LLC

    RECRUITING

    Greensboro, North Carolina, 27410, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Vista Clinical Research

    RECRUITING

    Newnan, Georgia, 30265, United States

  • Well Pharma Medical Research Corp

    RECRUITING

    Miami, Florida, 33143, United States

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Willow Rheumatology and Wellness

    RECRUITING

    Willowbrook, Illinois, 60527, United States

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