Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | RECRUITING | 270 | — | — | Feb 9, 2026 | Jul 18, 2028 | May 4, 2026 | 37 | United States, Puerto Rico |
Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.
| Arm | Type | Description |
|---|---|---|
| Pegloticase SC with MTX | EXPERIMENTAL | Participants will receive pegloticase SC every two weeks with MTX. |
| Pegloticase IV with MTX | EXPERIMENTAL | Participants will receive pegloticase IV every two weeks with MTX. |
| Name | Type | Description |
|---|---|---|
| Pegloticase | DRUG | Participants will receive pegloticase either SC or IV. |
| Methotrexate | DRUG | MTX will be administered orally. |
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...