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

Recruiting now · Phase 3

Conditions studied: Uncontrolled Gout

In brief

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.

Key facts

Study ID

NCT07388498

Run by

Amgen

People needed

270

Starts

2026-02-09

Expected to finish

2028-06-18

Last updated by the study team

2026-08-07

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orthopedic Physicians Alaska — Anchorage, Alaska, United States (enrolling)
• Precision Rheumatology — Anaheim, California, United States (enrolling)
• Advanced Clinical Research Center, LLC dba TriWest Research Associates — Chula Vista, California, United States (enrolling)
• Solace Clinical Research — Tustin, California, United States (enrolling)
• Denver Arthritis Clinic PC — Denver, Colorado, United States (enrolling)
• D and H Pompano Research Center — Aventura, Florida, United States (enrolling)
• Bay Pines Veterans Affairs Healthcare System — Bay Pines, Florida, United States (enrolling)
• Hillcrest Medical Research — DeLand, Florida, United States (enrolling)
• New Generation of Medical Research — Hialeah, Florida, United States (enrolling)
• Homestead Associates In Research Inc — Homestead, Florida, United States (enrolling)
• Pharmax Research Clinic — Miami, Florida, United States (enrolling)
• Well Pharma Medical Research Corp — Miami, Florida, United States (enrolling)
• D and H National Research Centers — Miami, Florida, United States (enrolling)
• Advanced Clinical Research — Miami, Florida, United States (enrolling)
• Entrust Clinical Research — Miami, Florida, United States (enrolling)
• Felicidad Medical Research — Miami, Florida, United States (enrolling)
• Decision Management International Research — Pinellas Park, Florida, United States (enrolling)
• Integral Rheumatology and Immunology Specialists — Plantation, Florida, United States (enrolling)
• D and H Tamarac Research Center — Tamarac, Florida, United States (enrolling)
• Nodal Medical Center Research — Tampa, Florida, United States (enrolling)
• GCP Clinical Research, LLC — Tampa, Florida, United States (enrolling)
• ClinPro Research Solutions LLC — Tampa, Florida, United States (enrolling)
• Conquest Research - Winter Park — Winter Park, Florida, United States (enrolling)
• Spatium Urgent Care — Marietta, Georgia, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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