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NCT07388498PHASE3Recruiting

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

Amgen

Start Date

2/9/2026

Completion Date

6/18/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Pegloticase

DRUG

Methotrexate

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Conditions

Uncontrolled Gout

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Orthopedic Physicians Alaska

Anchorage, Alaska 99508

United States

Advanced Clinical Research Center, LLC dba TriWest Research Associates

Chula Vista, California 91910

United States

Solace Clinical Research

Tustin, California 92780

United States

Denver Arthritis Clinic PC

Denver, Colorado 80230

United States

D and H Pompano Research Center

Aventura, Florida 33180

United States

Bay Pines Veterans Affairs Healthcare System

Bay Pines, Florida 33744

United States

Hillcrest Medical Research

DeLand, Florida 32720

United States

New Generation of Medical Research

Hialeah, Florida 33016

United States

Homestead Associates In Research Inc

Homestead, Florida 33033

United States

Pharmax Research Clinic

Miami, Florida 33126

United States

Well Pharma Medical Research Corp

Miami, Florida 33143

United States

D and H National Research Centers

Miami, Florida 33155

United States

Advanced Clinical Research

Miami, Florida 33156

United States

Entrust Clinical Research

Miami, Florida 33176

United States

Felicidad Medical Research

Miami, Florida 33184

United States

Decision Management International Research

Pinellas Park, Florida 33782

United States

Integral Rheumatology and Immunology Specialists

Plantation, Florida 33324

United States

D and H Tamarac Research Center

Tamarac, Florida 33321

United States

Nodal Medical Center Research

Tampa, Florida 33607

United States

GCP Clinical Research, LLC

Tampa, Florida 33609

United States

ClinPro Research Solutions LLC

Tampa, Florida 33613

United States

Conquest Research - Winter Park

Winter Park, Florida 32789

United States

Spatium Urgent Care

Marietta, Georgia 30066

United States

Vista Clinical Research

Newnan, Georgia 30265

United States

Charter Research

Chicago, Illinois 60618

United States

Flourish Research Ravenswood

Chicago, Illinois 60640

United States

Greater Chicago Specialty Physicians

Schaumburg, Illinois 60195

United States

Willow Rheumatology and Wellness

Willowbrook, Illinois 60527

United States

Mandeville Private Physicians Group

Mandeville, Louisiana 70471

United States

Kur Research at Columbia Medical Practice

Columbia, Maryland 21045

United States

MD Medical Research

Oxon Hill, Maryland 20745

United States

Raymond G Murphy Veteran Affairs Medical Center

Albuquerque, New Mexico 87108

United States

Buffalo Rheumatology and Medicine

Orchard Park, New York 14127

United States

Joint and Muscle Research Institute

Charlotte, North Carolina 28204

United States

Onsite Clinical Solutions, LLC

Charlotte, North Carolina 28211

United States

Research Carolina Elite

Denver, North Carolina 28037

United States

Triad Clinical Trials, LLC

Greensboro, North Carolina 27410

United States

Cape Fear Arthritis Care, PLLC

Leland, North Carolina 28451

United States

Accellacare Salisbury

Salisbury, North Carolina 28144

United States

Carolina Research Center Inc

Shelby, North Carolina 28150

United States

Shelby Clinical Research

Shelby, North Carolina 28150

United States

Paramount Medical Research and Consulting LLC

Middleburg Heights, Ohio 44130

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma 73111

United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania 16635

United States

Articularis Healthcare Group Inc dba Low Country Rheumatology

Summerville, South Carolina 29486

United States

Southwest Rheumatology

Dallas, Texas 75230

United States

Research Physicians Network, LLC

Houston, Texas 77089

United States

Pioneer Research Solutions Inc

Houston, Texas 77099

United States

Texas Arthritis & Rheumatology Associates

Katy, Texas 77450

United States

Biopharma Informatic, LLC

Katy, Texas 77494

United States

Epic Clinical Research

Lewisville, Texas 75057

United States

Be Well Clinical Studies

Round Rock, Texas 78681

United States

Siena Research Network

Sugar Land, Texas 77479

United States

Overlake Arthritis and Osteoperosis Center

Bellevue, Washington 98004

United States

Arthritis Northwest Professional Limited Liability Company

Spokane, Washington 99204

United States

Caribbean Health Research Center

San Juan, 00917

Puerto Rico