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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
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

RecruitingPhase 3

Sponsor: Amgen

Conditions: Uncontrolled Gout

Interventions: Pegloticase, Methotrexate

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (63)
  • Birmingham, Alabama, United States
  • Anchorage, Alaska, United States
  • Anaheim, California, United States
  • Chula Vista, California, United States
  • Tustin, California, United States
  • Denver, Colorado, United States
  • Aventura, Florida, United States
  • Bay Pines, Florida, United States
  • DeLand, Florida, United States
  • Hialeah, Florida, United States
  • Homestead, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Pinellas Park, Florida, United States
  • Plantation, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Marietta, Georgia, United States
  • Newnan, Georgia, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Schaumburg, Illinois, United States
  • + 33 more on CT.gov