A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
NCT ID: NCT06229145
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
262 participants
INTERVENTIONAL
2024-03-18
2026-03-12
Brief Summary
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The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pegloticase + Methotrexate Q4W
16 mg pegloticase will be administered intravenously every 4 weeks for 24 weeks during double blind treatment and 24 weeks during open label.
Pegloticase
IV infusion
Methotrexate
Oral
Pegloticase + Methotrexate Q2W
8 mg pegloticase will be administered intravenously every 2 weeks for 24 weeks during double blind treatment and 16 mg pegloticase every 4 weeks for 24 weeks during open label.
Pegloticase
IV infusion
Methotrexate
Oral
Interventions
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Pegloticase
IV infusion
Methotrexate
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Orthopedic Physicians Alaska - Rheumatology and Infusion
Anchorage, Alaska, United States
Arizona Arthritis and Rheumatology Associates - Chandler
Chandler, Arizona, United States
Arizona Arthritis and Rheumatology Rese
Flagstaff, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Research
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, United States
Arizona Arthritis and Rheumatology
Tucson, Arizona, United States
Covina Arthritis Clinic
Covina, California, United States
Medvin Clinical Research- Riverside
Hemet, California, United States
Velocity Clinical Research - Boise - ERN - PPDS
North Hollywood, California, United States
TriWest Research Associates
San Diego, California, United States
Precision Comprehensive Clinical Research Solutions
San Leandro, California, United States
Saint John's Health Center - Providence St John's Health Ctr
Santa Monica, California, United States
C.V. Mehta MD Medical Corporation
Temecula, California, United States
Foothill Arthritis
Tujunga, California, United States
Medvin Clinical Research
Whittier, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Denver Arthritis Clinic - Rheumatology
Denver, Colorado, United States
Arthritis & Rheumatic Disease
Aventura, Florida, United States
Prohealth Research Center
Doral, Florida, United States
Life Clinical Trials
Margate, Florida, United States
Homestead Associates in Research,Inc
Miami, Florida, United States
D&H National Research Centers, Inc.
Miami, Florida, United States
Well Pharma
Miami, Florida, United States
Felicidad Medical Research, LLC.
Miami, Florida, United States
New Generation Of Medical Research
Naples, Florida, United States
IRIS Research & Development
Plantation, Florida, United States
D&H Pompano Research Center
Pompano Beach, Florida, United States
D&H Tamarac Research Center
Tamarac, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
ClinPro Research Solutions, LLC
Tampa, Florida, United States
Arthritis Center of North Georgia
Gainesville, Georgia, United States
Vista Clinical Research, LLC
Newnan, Georgia, United States
Great Lakes Clin. Trials
Chicago, Illinois, United States
Conquest Research - Anesthesiology/Pain Medicine
Chicago, Illinois, United States
Great Lakes Clinical Trials - Gurnee
Highland Park, Illinois, United States
Crowley CORE - Illinois Bone and Joint Institute
Hinsdale, Illinois, United States
Lake Cumberland Rheumatology, PLLC
New Albany, Indiana, United States
L-MARC Research Center
Louisville, Kentucky, United States
Velocity CR - New Orleans
Covington, Louisiana, United States
Velocity CR - New Orleans
New Orleans, Louisiana, United States
Michigan Medicine
Ann Arbor, Michigan, United States
June DO,PC
Lansing, Michigan, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, United States
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, United States
Velocity Clinical Research-Vestal
Vestal, New York, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Research Carolina Elite
Denver, North Carolina, United States
Triad Clinical Trials - Gastroenterology
Greensboro, North Carolina, United States
Accellacare of Hickory
Hickory, North Carolina, United States
Cape Fear Arthritis Care
Leland, North Carolina, United States
Shelby Clinical Research - Family Medicine
Shelby, North Carolina, United States
Velocity Clinical Research- Cincinatti
Cincinnati, Ohio, United States
Velocity Clinical Research - Cleveland
Cleveland, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Velocity Clinical Research, Spartanburg - Pulmonology
Greenville, South Carolina, United States
Premier Clinics Pa - Rock Hill, Sc
Rock Hill, South Carolina, United States
Low Country Rheumatology
Summerville, South Carolina, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States
Clinical Trial Network
Austin, Texas, United States
Synergy Groups Medical LLC
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
AIM Trials - Internal Medicine
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Texas Research Center
Sugar Land, Texas, United States
Velocity Clinical Research - Salt Lake City (West Jordan)
West Jordan, Utah, United States
Velocity Clinical Research-Portsmouth
Portsmouth, Virginia, United States
Arthritis Northwest, PLLC - Research
Spokane, Washington, United States
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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HZNP-KRY-409
Identifier Type: -
Identifier Source: org_study_id
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