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
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Amgen
- Study ID
- NCT07388498
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Uncontrolled Gout
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pegloticase — DRUGParticipants will receive pegloticase either SC or IV.
- Methotrexate — DRUGMTX will be administered orally.
Study Details
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.
Key Dates
- Start date
- Feb 9, 2026
- Status verified
- Jun 2026
- Primary completion
- Jun 18, 2028
- Completion
- Jun 18, 2028
Study Design
- Enrollment
- 270 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pegloticase SC with MTXParticipants will receive pegloticase SC every two weeks with MTX.
- Experimental: Pegloticase IV with MTXParticipants will receive pegloticase IV every two weeks with MTX.
Primary Outcome Measure
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24 [ Time Frame: Month 6 (Weeks 20, 21, 22, 23, and 24) ]
Central Contacts
- Amgen Call Center866-572-6436