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

NCT07388498 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 20230219
• Study Type: interventional
• Target: 270
• Locations: 2 countries
• Sites: 37

Brief Summary

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.

Conditions

Uncontrolled Gout

Keywords

Uncontrolled Gout; Pegloticase; KRYSTEXXA; Kadence

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Month 6 Response at 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 Outcomes (4)

• Number of Participants With Serious Injection Site Reactions Through Week 48

  Up to Week 48

• Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48

  Up to Week 48

• Number of Participants With Adjudicated Anaphylaxis Through Week 48

  Up to Week 48

• Serum Concentrations of Pegloticase Following SC and IV Administration

  Up to Week 48

Study Arms (2)

Pegloticase SC with MTX

EXPERIMENTAL

Participants will receive pegloticase SC every two weeks with MTX.

Drug: Pegloticase; Drug: Methotrexate

Pegloticase IV with MTX

EXPERIMENTAL

Participants will receive pegloticase IV every two weeks with MTX.

Drug: Pegloticase; Drug: Methotrexate

Interventions

Pegloticase DRUG

Participants will receive pegloticase either SC or IV.

Also known as: KRYSTEXXA

Pegloticase IV with MTX; Pegloticase SC with MTX

Methotrexate DRUG

MTX will be administered orally.

Also known as: MTX

Pegloticase IV with MTX; Pegloticase SC with MTX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (37)

Solace Clinical Research

Tustin, California, 92780, United States

RECRUITING

Denver Arthritis Clinic PC

Denver, Colorado, 80230, United States

RECRUITING

D and H Pompano Research Center

Aventura, Florida, 33180, United States

RECRUITING

New Generation of Medical Research

Hialeah, Florida, 33016, United States

RECRUITING

Homestead Associates In Research Inc

Homestead, Florida, 33033, United States

RECRUITING

Well Pharma Medical Research Corp

Miami, Florida, 33143, United States

RECRUITING

D and H National Research Centers

Miami, Florida, 33155, United States

RECRUITING

Advanced Clinical Research

Miami, Florida, 33156, United States

RECRUITING

Felicidad Medical Research

Miami, Florida, 33184, United States

RECRUITING

Decision Management International Research

Pinellas Park, Florida, 33782, United States

RECRUITING

Integral Rheumatology and Immunology Specialists

Plantation, Florida, 33324, United States

RECRUITING

D and H Tamarac Research Center

Tamarac, Florida, 33321, United States

RECRUITING

GCP Clinical Research, LLC

Tampa, Florida, 33609, United States

RECRUITING

ClinPro Research Solutions LLC

Tampa, Florida, 33613, United States

RECRUITING

Conquest Research - Winter Park

Winter Park, Florida, 32789, United States

RECRUITING

Spatium Urgent Care

Marietta, Georgia, 30066, United States

RECRUITING

Vista Clinical Research

Newnan, Georgia, 30265, United States

RECRUITING

Charter Research

Chicago, Illinois, 60618, United States

RECRUITING

Flourish Research Ravenswood

Chicago, Illinois, 60640, United States

RECRUITING

Greater Chicago Specialty Physicians

Schaumburg, Illinois, 60195, United States

RECRUITING

Willow Rheumatology and Wellness

Willowbrook, Illinois, 60527, United States

RECRUITING

Kur Research at Columbia Medical Practice

Columbia, Maryland, 21045, United States

RECRUITING

MD Medical Research

Oxon Hill, Maryland, 20745, United States

RECRUITING

Buffalo Rheumatology and Medicine

Orchard Park, New York, 14127, United States

RECRUITING

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Cape Fear Arthritis Care, PLLC

Leland, North Carolina, 28451, United States

RECRUITING

Accellacare Salisbury

Salisbury, North Carolina, 28144, United States

RECRUITING

Carolina Research Center Inc

Shelby, North Carolina, 28150, United States

RECRUITING

Shelby Clinical Research

Shelby, North Carolina, 28150, United States

RECRUITING

Paramount Medical Research and Consulting LLC

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Articularis Healthcare Group Inc dba Low Country Rheumatology

Summerville, South Carolina, 29486, United States

RECRUITING

Pioneer Research Solutions Inc

Houston, Texas, 77099, United States

RECRUITING

Epic Clinical Research

Lewisville, Texas, 75057, United States

RECRUITING

Be Well Clinical Studies

Round Rock, Texas, 78681, United States

RECRUITING

Overlake Arthritis and Osteoperosis Center

Bellevue, Washington, 98004, United States

RECRUITING

Caribbean Health Research Center

San Juan, 00917, Puerto Rico

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Pegloticase; Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): May 23, 2028
• Study Completion (Estimated): July 18, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (36); PR (1)