Gout drug study aims for fewer infusions, same relief

NCT ID NCT06229145

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tested whether a gout medication (pegloticase) given every 4 weeks works as well as the standard every-2-week schedule, when both are paired with weekly methotrexate. The goal was to lower uric acid levels in people with severe, hard-to-treat gout. About 262 adults with uncontrolled gout took part in this completed Phase 4 trial.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

306 people

The number who actually took part.

Started

Mar 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult men or women ≥ 18 years of age 2. Uncontrolled gout, defined as meeting the following criteria: * Hyperuricemia during the Screening Period, defined as sUA ≥ 7 mg/dL, and; * Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or participant interview, and; * Symptoms of gout 3. Willing to discontinue any oral ULT for at least 7 days prior to MTX dosing at Week -4 and continue not receiving any oral ULT when receiving pegloticase/placebo for pegloticase infusions 4. Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4. 5. Men who are not vasectomized must agree to use appropriate contraception, so as to not impregnate a female partner of reproductive potential during the trial. Exclusion Criteria: 1. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis 2. Current or chronic treatment with systemic immunosuppressive agents, such as MTX, azathioprine or mycophenolate mofetil; prednisone \> 10 mg/day or equivalent dose of other corticosteroid on a chronic basis (3 months or longer) 3. History of any transplant surgery requiring maintenance immunosuppressive therapy 4. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity 5. Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative 6. Known history of human immunodeficiency virus (HIV) positivity 7. G6PD deficiency (quantitative test at the Screening Visit centrally or locally) 8. Non-compensated congestive heart failure or hospitalization for congestive heart failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina) or uncontrolled blood pressure (\> 160/100 mmHg) prior to Week -4 9. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female partner or not on an effective form of birth control, as determined by the Investigator 10. Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug 11. Unable to tolerate MTX 15 mg orally during the MTX Run-in Period 12. Chronic liver disease 13. White blood cell count \< 4,000/μL, hematocrit \< 32% or platelet count \< 75,000/μL 14. Currently receiving systemic or radiologic treatment for ongoing cancer 15. History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix 16. Diagnosis of osteomyelitis 17. Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome 18. A known intolerance to all protocol-standard gout flare prophylaxis regimens (i.e., participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day) 19. Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout

Contacts and locations

Locations

AIM Trials - Internal Medicine

Plano, Texas, 75093, United States
Accellacare of Hickory

Hickory, North Carolina, 28602, United States
Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States
Amarillo Center for Clinical Research, Ltd.

Amarillo, Texas, 79124, United States
Arizona Arthritis & Rheumatology Research, PLLC

Gilbert, Arizona, 85297, United States
Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85032, United States
Arizona Arthritis & Rheumatology Research, PLLC

Sun City, Arizona, 85351, United States
Arizona Arthritis and Rheumatology

Tucson, Arizona, 85704, United States
Arizona Arthritis and Rheumatology Associates - Chandler

Chandler, Arizona, 85225-2915, United States
Arizona Arthritis and Rheumatology Rese

Flagstaff, Arizona, 86001, United States
Arizona Arthritis and Rheumatology Research

Phoenix, Arizona, 85037, United States
Arizona Arthritis and Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States
Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, 85037-4403, United States
Arthritis & Rheumatic Disease

Aventura, Florida, 33180-1204, United States
Arthritis Center of North Georgia

Gainesville, Georgia, 30501, United States
Arthritis Northwest, PLLC - Research

Spokane, Washington, 99204, United States
C.V. Mehta MD Medical Corporation

Temecula, California, 92592, United States
Cape Fear Arthritis Care

Leland, North Carolina, 28451-4168, United States
ClinPro Research Solutions, LLC

Tampa, Florida, 33613, United States
Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, 48081, United States
Clinical Trial Network

Austin, Texas, 78750, United States
Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States
Conquest Research - Anesthesiology/Pain Medicine

Chicago, Illinois, 60637, United States
Covina Arthritis Clinic

Covina, California, 91722, United States
Crowley CORE - Illinois Bone and Joint Institute

Hinsdale, Illinois, 60521, United States
D&H National Research Centers, Inc.

Miami, Florida, 33155, United States
D&H Pompano Research Center

Pompano Beach, Florida, 33064, United States
D&H Tamarac Research Center

Tamarac, Florida, 33321, United States
Denver Arthritis Clinic - Rheumatology

Denver, Colorado, 80230, United States
Felicidad Medical Research, LLC.

Miami, Florida, 33184, United States
Foothill Arthritis

Tujunga, California, 91042, United States
GCP Clinical Research

Tampa, Florida, 33609, United States
Great Lakes Clin. Trials

Chicago, Illinois, 60625, United States
Great Lakes Clinical Trials - Gurnee

Highland Park, Illinois, 60035, United States
Homestead Associates in Research,Inc

Miami, Florida, 33032-8225, United States
IRIS Research & Development

Plantation, Florida, 33324, United States
Inspire Santa Fe Medical Group

Santa Fe, New Mexico, 87505, United States
June DO,PC

Lansing, Michigan, 48911, United States
L-MARC Research Center

Louisville, Kentucky, 40213, United States
Lake Cumberland Rheumatology, PLLC

New Albany, Indiana, 47150, United States
Life Clinical Trials

Margate, Florida, 33063-5675, United States
Low Country Rheumatology

Summerville, South Carolina, 29486-7887, United States
Lynn Health Science Institute

Oklahoma City, Oklahoma, 73111-3324, United States
Lynn Institute of the Rockies

Colorado Springs, Colorado, 80918, United States
Medvin Clinical Research

Whittier, California, 90602, United States
Medvin Clinical Research- Riverside

Hemet, California, 92543, United States
Michigan Medicine

Ann Arbor, Michigan, 48109, United States
New Generation Of Medical Research

Naples, Florida, 34104, United States
OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28226, United States
Orthopedic Physicians Alaska - Rheumatology and Infusion

Anchorage, Alaska, 99508-5234, United States
Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States
Precision Comprehensive Clinical Research Solutions

San Leandro, California, 94578-2630, United States
Premier Clinics Pa - Rock Hill, Sc

Rock Hill, South Carolina, 29732, United States
Prohealth Research Center

Doral, Florida, 33166, United States
Research Carolina Elite

Denver, North Carolina, 28037, United States
Saint John's Health Center - Providence St John's Health Ctr

Santa Monica, California, 90404, United States
Shelby Clinical Research - Family Medicine

Shelby, North Carolina, 28152, United States
Synergy Groups Medical LLC

Houston, Texas, 77061, United States
Texas Research Center

Sugar Land, Texas, 77479, United States
The University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States
TriWest Research Associates

San Diego, California, 92108, United States
Triad Clinical Trials - Gastroenterology

Greensboro, North Carolina, 27410, United States
University of Colorado Denver

Aurora, Colorado, 80045, United States
Velocity CR - New Orleans

Covington, Louisiana, 70433, United States
Velocity CR - New Orleans

New Orleans, Louisiana, 70121-2429, United States
Velocity Clinical Research - Boise - ERN - PPDS

North Hollywood, California, 83642, United States
Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122, United States
Velocity Clinical Research - Salt Lake City (West Jordan)

West Jordan, Utah, 84088, United States
Velocity Clinical Research, Spartanburg - Pulmonology

Greenville, South Carolina, 29615, United States
Velocity Clinical Research- Cincinatti

Cincinnati, Ohio, 45242, United States
Velocity Clinical Research-Portsmouth

Portsmouth, Virginia, 23703-3200, United States
Velocity Clinical Research-Vestal

Vestal, New York, 13850, United States
Vista Clinical Research, LLC

Newnan, Georgia, 30265, United States
Well Pharma

Miami, Florida, 33173, United States

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