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

Conditions

• Uncontrolled Gout

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pegloticase — DRUG
  Participants will receive pegloticase either SC or IV.
• Methotrexate — DRUG
  MTX 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

First listed

Feb 5, 2026

Start date

Feb 9, 2026

Status verified

Sep 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 MTX
  Participants will receive pegloticase SC every two weeks with MTX.
• Experimental: Pegloticase IV with MTX
  Participants 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 Center
  866-572-6436
  [email protected]

Locations (70)

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