drugset / Trial / NCT07388498
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
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2026-02-09
- Primary completion
- 2028-06-18
- Completion
- 2028-06-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegloticase | Protein / enzyme biologic | 8 mg | Subcutaneous |
| Subject | Pegloticase | Protein / enzyme biologic | 18 mg | Subcutaneous |
| Background | Methotrexate | Small molecule | — | Oral |