RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Amgen • ClinicalTrials.gov ID: NCT07388498

Registry updated: 2026-10-19

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Description

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.

Interventions

Pegloticase (Drug)
Participants will receive pegloticase either SC or IV.
Methotrexate (Drug)
MTX will be administered orally.

Eligibility criteria

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.

Conditions

Uncontrolled Gout

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States
Orthopedic Physicians Alaska — Anchorage, Alaska, United States
Unity Health Searcy Medical Center — Searcy, Arkansas, United States
Precision Rheumatology — Anaheim, California, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates — Chula Vista, California, United States
Veterans Affairs Long Beach Health Care System — Long Beach, California, United States
Solace Clinical Research — Tustin, California, United States
Jiva Health — Walnut Creek, California, United States
Denver Arthritis Clinic PC — Denver, Colorado, United States
Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
D and H Pompano Research Center — Aventura, Florida, United States
Bay Pines Veterans Affairs Healthcare System — Bay Pines, Florida, United States
Discovery Health Research Center — Coral Springs, Florida, United States
Hillcrest Medical Research — DeLand, Florida, United States
New Generation of Medical Research — Hialeah, Florida, United States
Homestead Associates In Research Inc — Homestead, Florida, United States
Decision Management International Research — Largo, Florida, United States
Pharmax Research Clinic — Miami, Florida, United States
Well Pharma Medical Research Corp — Miami, Florida, United States
D and H National Research Centers — Miami, Florida, United States
Advanced Clinical Research — Miami, Florida, United States
Entrust Clinical Research — Miami, Florida, United States
Felicidad Medical Research — Miami, Florida, United States
Integral Rheumatology and Immunology Specialists — Plantation, Florida, United States
D and H Tamarac Research Center — Tamarac, Florida, United States
Nodal Medical Center Research — Tampa, Florida, United States
ClinPro Research Solutions LLC — Tampa, Florida, United States
GCP Clinical Research, LLC — Tampa, Florida, United States
Conquest Research - Winter Park — Winter Park, Florida, United States
Spatium Urgent Care — Marietta, Georgia, United States
Vista Clinical Research — Newnan, Georgia, United States
Greater Chicago Specialty Physicians — Boise, Idaho, United States
Saint Lukes Intermountain Research Center — Meridian, Idaho, United States
Charter Research — Chicago, Illinois, United States
Flourish Research Ravenswood — Chicago, Illinois, United States
Willow Rheumatology and Wellness — Willowbrook, Illinois, United States
Clinical Trials Management, LLC, d/b/a Flourish Research — Mandeville, Louisiana, United States
Kur Research at Columbia Medical Practice — Columbia, Maryland, United States
MD Medical Research — Oxon Hill, Maryland, United States
June DO PC — Lansing, Michigan, United States
Clinical Research Institute of Michigan — Saint Clair Shores, Michigan, United States
Oakland Medical Research Center — Troy, Michigan, United States
University of Kansas Medical Center — Kansas City, Missouri, United States
Bioluminux Clinical Research - Hamilton — Hamilton, New Jersey, United States
Raymond G Murphy Veteran Affairs Medical Center — Albuquerque, New Mexico, United States
Inspire Santa Fe Medical Group — Santa Fe, New Mexico, United States
Buffalo Rheumatology and Medicine — Orchard Park, New York, United States
Arthritis and Osteoporosis Consultants of the Carolinas — Charlotte, North Carolina, United States
Joint and Muscle Research Institute — Charlotte, North Carolina, United States
Onsite Clinical Solutions, LLC — Charlotte, North Carolina, United States
Research Carolina Elite — Denver, North Carolina, United States
Triad Clinical Trials, LLC — Greensboro, North Carolina, United States
Cape Fear Arthritis Care, PLLC — Leland, North Carolina, United States
Accellacare Salisbury — Salisbury, North Carolina, United States
Carolina Research Center Inc — Shelby, North Carolina, United States
Shelby Clinical Research — Shelby, North Carolina, United States
The Ohio State University — Columbus, Ohio, United States
Paramount Medical Research and Consulting LLC — Middleburg Heights, Ohio, United States
Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
Articularis Healthcare Group Inc dba Low Country Rheumatology — Summerville, South Carolina, United States
Health Concepts — Rapid City, South Dakota, United States
West Tennessee Research Institute — Jackson, Tennessee, United States
Pioneer Research Solutions Inc — Bellaire, Texas, United States
Southwest Rheumatology — Dallas, Texas, United States
Research Physicians Network, LLC — Houston, Texas, United States
Texas Arthritis & Rheumatology Associates — Katy, Texas, United States
Biopharma Informatic, LLC — Katy, Texas, United States
Epic Clinical Research — Lewisville, Texas, United States
Be Well Clinical Studies — Round Rock, Texas, United States
Siena Research Network — Sugar Land, Texas, United States
Advanced Rheumatology of Houston — The Woodlands, Texas, United States
Virginia Commonwealth University — Richmond, Virginia, United States
Overlake Arthritis and Osteoperosis Center — Bellevue, Washington, United States
Caribbean Health Research Center — San Juan, Puerto Rico

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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