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Clinical Trials in the USA / NCT07388498
Recruiting Phase 3

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

NCT07388498 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2026-02-09
Last updated
2026-09-03

Condition(s) studied

Uncontrolled Gout

Investigational drug(s) / intervention(s)

PegloticaseMethotrexate

Pegloticase: Participants will receive pegloticase either SC or IV.

Methotrexate: MTX will be administered orally.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Orthopedic Physicians Alaska Anchorage Alaska Recruiting
Precision Rheumatology Anaheim California Recruiting
Advanced Clinical Research Center, LLC dba TriWest Research Associates Chula Vista California Recruiting
Solace Clinical Research Tustin California Recruiting
Denver Arthritis Clinic PC Denver Colorado Recruiting
Arthritis and Rheumatic Disease Specialties Aventura Florida Recruiting
D and H Pompano Research Center Aventura Florida Recruiting
Bay Pines Veterans Affairs Healthcare System Bay Pines Florida Recruiting
Discovery Health Research Center Coral Springs Florida Recruiting
Hillcrest Medical Research DeLand Florida Recruiting
New Generation of Medical Research Hialeah Florida Recruiting
Homestead Associates In Research Inc Homestead Florida Recruiting
Pharmax Research Clinic Miami Florida Recruiting
Well Pharma Medical Research Corp Miami Florida Recruiting
D and H National Research Centers Miami Florida Recruiting
Advanced Clinical Research Miami Florida Recruiting
Entrust Clinical Research Miami Florida Recruiting
Felicidad Medical Research Miami Florida Recruiting
Decision Management International Research Pinellas Park Florida Recruiting
Integral Rheumatology and Immunology Specialists Plantation Florida Recruiting
D and H Tamarac Research Center Tamarac Florida Recruiting
Nodal Medical Center Research Tampa Florida Recruiting
GCP Clinical Research, LLC Tampa Florida Recruiting
ClinPro Research Solutions LLC Tampa Florida Recruiting
Conquest Research - Winter Park Winter Park Florida Recruiting
Spatium Urgent Care Marietta Georgia Recruiting
Vista Clinical Research Newnan Georgia Recruiting
Saint Lukes Intermountain Research Center Boise Idaho Recruiting
Charter Research Chicago Illinois Recruiting
Flourish Research Ravenswood Chicago Illinois Recruiting
Greater Chicago Specialty Physicians Schaumburg Illinois Recruiting
Willow Rheumatology and Wellness Willowbrook Illinois Recruiting
Clinical Trials Management, LLC, d/b/a Flourish Research Mandeville Louisiana Recruiting
Kur Research at Columbia Medical Practice Columbia Maryland Recruiting
MD Medical Research Oxon Hill Maryland Recruiting
June DO PC Lansing Michigan Recruiting
Clinical Research Institute of Michigan Saint Clair Shores Michigan Recruiting
Oakland Medical Research Center Troy Michigan Recruiting
Bioluminux Clinical Research - Hamilton Hamilton New Jersey Recruiting

+ 31 more sites — see the full list on the official registry below.

More Amgen trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07388498 on ClinicalTrials.gov ↗ ← All trials in the USA