Skip to main content
← All trials
Uncontrolled GoutDrugPhase 3

What this study is

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.

What's being tested

  • Pegloticase

    Intervention · DRUG

    Participants will receive pegloticase either SC or IV.

  • Methotrexate

    Intervention · DRUG

    MTX will be administered orally.

Study details

Official title
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
Sponsor
Amgen
Conditions
Uncontrolled Gout
Enrolling
270 people
Starts
2026-02-09
Est. completion
2028-06-18
Design
Double-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗