Recruiting

Phase 3

Pegloticase vs. PegloticaseA 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

Code:

NCT07388498

Conditions

Uncontrolled Gout

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pegloticase

Methotrexate

Study Details

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

Study ID

NCT07388498

Start date

Feb 9, 2026

Status verified date

Aug, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pegloticase SC with MTX

Participants will receive pegloticase SC every two weeks with MTX.

experimental: Pegloticase IV with MTX

Participants will receive pegloticase IV every two weeks with MTX.

Interventions

Pegloticase

Participants will receive pegloticase either SC or IV.

Methotrexate

MTX will be administered orally.

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436 medinfo@amgen.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Orthopedic Physicians Alaska

Recruiting

Anchorage, Alaska, United States, 99508

Precision Rheumatology

Recruiting

Anaheim, California, United States, 92802

Advanced Clinical Research Center, LLC dba TriWest Research Associates

Recruiting

Chula Vista, California, United States, 91910

Solace Clinical Research

Recruiting

Tustin, California, United States, 92780

Denver Arthritis Clinic PC

Recruiting

Denver, Colorado, United States, 80230

D and H Pompano Research Center

Recruiting

Aventura, Florida, United States, 33180

Bay Pines Veterans Affairs Healthcare System

Recruiting

Bay Pines, Florida, United States, 33744

Hillcrest Medical Research

Recruiting

DeLand, Florida, United States, 32720

New Generation of Medical Research

Recruiting

Hialeah, Florida, United States, 33016

Homestead Associates In Research Inc

Recruiting

Homestead, Florida, United States, 33033

Pharmax Research Clinic

Recruiting

Miami, Florida, United States, 33126

Well Pharma Medical Research Corp

Recruiting

Miami, Florida, United States, 33143

D and H National Research Centers

Recruiting

Miami, Florida, United States, 33155

Advanced Clinical Research

Recruiting

Miami, Florida, United States, 33156

Entrust Clinical Research

Recruiting

Miami, Florida, United States, 33176

Felicidad Medical Research

Recruiting

Miami, Florida, United States, 33184

Decision Management International Research

Recruiting

Pinellas Park, Florida, United States, 33782

Integral Rheumatology and Immunology Specialists

Recruiting

Plantation, Florida, United States, 33324

D and H Tamarac Research Center

Recruiting

Tamarac, Florida, United States, 33321

Nodal Medical Center Research

Recruiting

Tampa, Florida, United States, 33607

GCP Clinical Research, LLC

Recruiting

Tampa, Florida, United States, 33609

ClinPro Research Solutions LLC

Recruiting

Tampa, Florida, United States, 33613

Conquest Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Spatium Urgent Care

Recruiting

Marietta, Georgia, United States, 30066

Vista Clinical Research

Recruiting

Newnan, Georgia, United States, 30265

Saint Lukes Intermountain Research Center

Recruiting

Boise, Idaho, United States, 83702

Charter Research

Recruiting

Chicago, Illinois, United States, 60618

Flourish Research Ravenswood

Recruiting

Chicago, Illinois, United States, 60640

Greater Chicago Specialty Physicians

Recruiting

Schaumburg, Illinois, United States, 60195

Willow Rheumatology and Wellness

Recruiting

Willowbrook, Illinois, United States, 60527

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

Recruiting

Mandeville, Louisiana, United States, 70471

Kur Research at Columbia Medical Practice

Recruiting

Columbia, Maryland, United States, 21045

MD Medical Research

Recruiting

Oxon Hill, Maryland, United States, 20745

Clinical Research Institute of Michigan

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Raymond G Murphy Veteran Affairs Medical Center

Recruiting

Albuquerque, New Mexico, United States, 87108

Inspire Santa Fe Medical Group

Recruiting

Santa Fe, New Mexico, United States, 87505

Buffalo Rheumatology and Medicine

Recruiting

Orchard Park, New York, United States, 14127

Joint and Muscle Research Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Onsite Clinical Solutions, LLC

Recruiting

Charlotte, North Carolina, United States, 28211

Research Carolina Elite

Recruiting

Denver, North Carolina, United States, 28037

Triad Clinical Trials, LLC

Recruiting

Greensboro, North Carolina, United States, 27410

Cape Fear Arthritis Care, PLLC

Recruiting

Leland, North Carolina, United States, 28451

Accellacare Salisbury

Recruiting

Salisbury, North Carolina, United States, 28144

Carolina Research Center Inc

Recruiting

Shelby, North Carolina, United States, 28150

Shelby Clinical Research

Recruiting

Shelby, North Carolina, United States, 28150

Paramount Medical Research and Consulting LLC

Recruiting

Middleburg Heights, Ohio, United States, 44130

Lynn Health Science Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73111

Altoona Center for Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Articularis Healthcare Group Inc dba Low Country Rheumatology

Recruiting

Summerville, South Carolina, United States, 29486

Health Concepts

Recruiting

Rapid City, South Dakota, United States, 57702

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Southwest Rheumatology

Recruiting

Dallas, Texas, United States, 75230

Research Physicians Network, LLC

Recruiting

Houston, Texas, United States, 77089

Pioneer Research Solutions Inc

Recruiting

Houston, Texas, United States, 77099

Texas Arthritis & Rheumatology Associates

Recruiting

Katy, Texas, United States, 77450

Biopharma Informatic, LLC

Recruiting

Katy, Texas, United States, 77494

Epic Clinical Research

Recruiting

Lewisville, Texas, United States, 75057

Be Well Clinical Studies

Recruiting

Round Rock, Texas, United States, 78681

Siena Research Network

Recruiting

Sugar Land, Texas, United States, 77479

Overlake Arthritis and Osteoperosis Center

Recruiting

Bellevue, Washington, United States, 98004

Arthritis Northwest Professional Limited Liability Company

Recruiting

Spokane, Washington, United States, 99204

More Information

Sponsor

Amgen

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

Uncontrolled Gout
Pegloticase
KRYSTEXXA
Kadence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-07.