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Comparing subcutaneous versus intravenous pegloticase with methotrexate for uncontrolled gout

A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout

Phase 3 Interventional Amgen · NCT07388498

This test compares subcutaneous pegloticase plus methotrexate to intravenous pegloticase plus methotrexate to see which better keeps uric acid under control in adults with uncontrolled gout.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsprednisone, methotrexate
Locations37 sites (Tustin, California and 36 other locations)
Trial IDNCT07388498 on ClinicalTrials.gov

What this trial studies

Adults with uncontrolled gout are randomized in a double-blind, phase 3 trial to receive either pegloticase 18 mg subcutaneously every two weeks with methotrexate or pegloticase 8 mg intravenously every two weeks with methotrexate. The primary endpoint is the response rate at Month 6, defined as serum uric acid below 6 mg/dL for at least 80% of the time during that month. Safety and pharmacokinetics are monitored throughout, and participants must meet inclusion/exclusion criteria such as no G6PD deficiency, acceptable liver tests, and methotrexate tolerance. Dosing and laboratory visits occur at participating clinical sites in the United States.

Who should consider this trial

Good fit: Adults with uncontrolled gout who can take methotrexate, have acceptable liver tests, no G6PD deficiency, and are willing to attend study visits at the listed U.S. sites are ideal candidates.

Not a fit: Patients with G6PD deficiency, uncontrolled diabetes, significant liver enzyme abnormalities, known methotrexate intolerance, or prior treatment with pegloticase or other PEG-containing uricases are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the subcutaneous option could provide similar or better uric acid control with a more convenient administration route and potentially fewer infusion-related issues.

How similar studies have performed: Intravenous pegloticase is an approved therapy for refractory gout and smaller studies indicate that adding methotrexate can reduce immunogenicity and improve response, while subcutaneous pegloticase formulations are newer and still being validated in larger trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Tustin, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uncontrolled GoutPegloticaseKRYSTEXXAKadence
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.