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
← catalyst calendarNCT07388498 · readout in 669 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
270estimated
Sites
63
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-09 | actual | When the study began enrolling |
| Primary completion | 2028-06-18 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-18 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Uncontrolled Gout
Interventions
- Drug: Pegloticase — also filed as KRYSTEXXA
- Drug: Methotrexate — also filed as MTX
Primary outcome
what the primary-completion date above is the date OFNumber of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
measured Month 6 (Weeks 20, 21, 22, 23, and 24)
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