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

Completed · Phase 4

Conditions studied: Gout

In brief

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. 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.

Key facts

Study ID

NCT06229145

Run by

Amgen

People needed

262

Starts

2024-03-18

Expected to finish

2026-03-11

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult men or women ≥ 18 years of age
• 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
• 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
• Women of childbearing potential must have negative serum/urine pregnancy tests during screening and Week -4.
• 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.

You may not qualify if…

• Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis
• 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)
• History of any transplant surgery requiring maintenance immunosuppressive therapy
• Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity
• Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative
• Known history of human immunodeficiency virus (HIV) positivity
• G6PD deficiency (quantitative test at the Screening Visit centrally or locally)
• 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
• 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
• Prior treatment with pegloticase, another recombinant uricase (rasburicase) or concomitant therapy with a PEG-conjugated drug
• Unable to tolerate MTX 15 mg orally during the MTX Run-in Period
• Chronic liver disease
• White blood cell count < 4,000/μL, hematocrit < 32% or platelet count < 75,000/μL
• Currently receiving systemic or radiologic treatment for ongoing cancer
• History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix
• Diagnosis of osteomyelitis
• Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome
• 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)
• Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed necessary by the Investigator, a chest X-ray may be performed during Screening.

Where it is running

• 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
• The University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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