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Pegloticase

Phase 3

Uncontrolled Gout | Small molecule | Metabolic |Amgen Inc.|Last Updated: Jul 23, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical trial landscape

Pegloticase · 1 trial · 1 indication

Phase 3 1
NCT07388498A 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 GoutUncontrolled Gout
RECRUITING270 Analytics
PHASE3RECRUITING
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
Uncontrolled Gout
NCT07388498270
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Study Endpoints
Primary Endpoints
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Month 6 (Weeks 20, 21, 22, 23, and 24)

Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.

Secondary Endpoints
Number of Participants With Serious Injection Site Reactions Through Week 48
Up to Week 48
Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48
Up to Week 48
Number of Participants With Adjudicated Anaphylaxis Through Week 48
Up to Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pegloticase SC with MTXEXPERIMENTALParticipants will receive pegloticase SC every two weeks with MTX.
Pegloticase IV with MTXEXPERIMENTALParticipants will receive pegloticase IV every two weeks with MTX.
Interventions
NameTypeDescription
PegloticaseDRUGParticipants will receive pegloticase either SC or IV.
MethotrexateDRUGMTX will be administered orally.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria * Participant has provided informed consent before initiation of any trial-specific activities/procedures. * Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years. * Participants willing and able to comply with the prescribed treatment protocol and evaluat...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWJul 24, 2026NCT07388498lastUpdatePostDate: changed
LOWJul 24, 2026NCT07388498lastUpdatePostDate: changed
LOWJul 10, 2026NCT07388498lastUpdatePostDate: changed
LOWJul 10, 2026NCT07388498lastUpdatePostDate: changed
LOWJul 2, 2026NCT07388498lastUpdatePostDate: changed
LOWJul 2, 2026NCT07388498lastUpdatePostDate: changed
LOWJun 18, 2026NCT07388498lastUpdatePostDate: changed
LOWJun 18, 2026NCT07388498lastUpdatePostDate: changed
LOWJun 18, 2026NCT07388498lastUpdatePostDate: changed
LOWJun 10, 2026NCT07388498primaryCompletionDate: changed
LOWJun 10, 2026NCT07388498primaryCompletionDate: changed
LOWMay 26, 2026NCT07388498primaryCompletionDate: changed
LOWMay 24, 2026NCT07388498studyFirstPostDate: changed