A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout

June 9, 2026 updated by: Amgen

A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • Caribbean Health Research Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Orthopedic Physicians Alaska
    • California
      • Tustin, California, United States, 92780
        • Recruiting
        • Solace Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Denver Arthritis Clinic PC
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • D and H Pompano Research Center
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines Veterans Affairs Healthcare System
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Hillcrest Medical Research
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • New Generation of Medical Research
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Homestead Associates in Research Inc
      • Miami, Florida, United States, 33176
        • Recruiting
        • Entrust Clinical Research
      • Miami, Florida, United States, 33156
        • Recruiting
        • Advanced Clinical Research
      • Miami, Florida, United States, 33184
        • Recruiting
        • Felicidad Medical Research
      • Miami, Florida, United States, 33155
        • Recruiting
        • D and H National Research Centers
      • Miami, Florida, United States, 33126
        • Recruiting
        • Pharmax Research Clinic
      • Miami, Florida, United States, 33143
        • Recruiting
        • Well Pharma Medical Research Corp
      • Pinellas Park, Florida, United States, 33782
        • Recruiting
        • Decision Management International Research
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Integral Rheumatology and Immunology Specialists
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • D and H Tamarac Research Center
      • Tampa, Florida, United States, 33609
        • Recruiting
        • GCP Clinical Research, LLC
      • Tampa, Florida, United States, 33613
        • Recruiting
        • ClinPro Research Solutions LLC
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research - Winter Park
    • Georgia
      • Marietta, Georgia, United States, 30066
        • Recruiting
        • Spatium Urgent Care
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • Vista Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Flourish Research Ravenswood
      • Chicago, Illinois, United States, 60618
        • Recruiting
        • Charter Research
      • Schaumburg, Illinois, United States, 60195
        • Recruiting
        • Greater Chicago Specialty Physicians
      • Willowbrook, Illinois, United States, 60527
        • Recruiting
        • Willow Rheumatology and Wellness
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Recruiting
        • Kur Research at Columbia Medical Practice
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • MD Medical Research
    • New York
      • Orchard Park, New York, United States, 14127
        • Recruiting
        • Buffalo Rheumatology and Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Joint and Muscle Research Institute
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Onsite Clinical Solutions, LLC
      • Greensboro, North Carolina, United States, 27410
        • Recruiting
        • Triad Clinical Trials, LLC
      • Leland, North Carolina, United States, 28451
        • Recruiting
        • Cape Fear Arthritis Care, PLLC
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Accellacare Salisbury
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Shelby Clinical Research
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Carolina Research Center Inc
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research and Consulting LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73111
        • Recruiting
        • Lynn Health Science Institute
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Articularis Healthcare Group Inc dba Low Country Rheumatology
    • Texas
      • Houston, Texas, United States, 77089
        • Recruiting
        • Research Physicians Network, LLC
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneer Research Solutions Inc
      • Katy, Texas, United States, 77494
        • Recruiting
        • Biopharma Informatic, LLC
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • Epic Clinical Research
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Be Well Clinical Studies
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Overlake Arthritis and Osteoperosis Center
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Arthritis Northwest Professional Limited Liability Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pegloticase SC with MTX
Participants will receive pegloticase SC every two weeks with MTX.
Drug: Pegloticase
Participants will receive pegloticase either SC or IV.
Other Names:
  • KRYSTEXXA
Drug: Methotrexate
MTX will be administered orally.
Other Names:
  • MTX
Experimental: Pegloticase IV with MTX
Participants will receive pegloticase IV every two weeks with MTX.
Drug: Pegloticase
Participants will receive pegloticase either SC or IV.
Other Names:
  • KRYSTEXXA
Drug: Methotrexate
MTX will be administered orally.
Other Names:
  • MTX

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Time Frame: Month 6 (Weeks 20, 21, 22, 23, and 24)
Defined as Achieving and Maintaining sUA < 6 mg/dL for at Least 80% of the Time During Month 6.
Month 6 (Weeks 20, 21, 22, 23, and 24)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With Serious Injection Site Reactions Through Week 48
Time Frame: Up to Week 48
Up to Week 48
Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48
Time Frame: Up to Week 48
Up to Week 48
Number of Participants With Adjudicated Anaphylaxis Through Week 48
Time Frame: Up to Week 48
Up to Week 48
Serum Concentrations of Pegloticase Following SC and IV Administration
Time Frame: Up to Week 48
Up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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